FDA event 78706 · Recall Observatory

device · product 1 of 48

BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement

Z-1014-2018

Recall number: Z-1014-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-5001-048-00 Lot Number: 62202263

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 2 of 48

CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Z-1015-2018

Recall number: Z-1015-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-8114-002-18 Lot Number: 61750651

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 3 of 48

CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Z-1016-2018

Recall number: Z-1016-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-8114-000-00 Lot Numbers: 61779346 61783708

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 4 of 48

CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Z-1017-2018

Recall number: Z-1017-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-8114-001-10 Lot Number: 61767833

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 5 of 48

CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Z-1018-2018

Recall number: Z-1018-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-8114-002-10 Lot Numbers: 61744467 61762055 61783714 62249024 62249025 62250377 62250378 62257221 62257223 62261916 62261917

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 6 of 48

CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Z-1019-2018

Recall number: Z-1019-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-8114-002-00 Lot Numbers: 62326105 61779347 62327662 62240744 62327663 62240745 62330760 62250379 62333960 62256011 62340054 62264280 62344682 62268572 62370963 62273048 62370965 62273049 62370966 62275085 62298278 62276441 62370975 62277490 62298279 62370968 62303495 62370969 62317907 62278684 62320168 62284463 62320169 62370971 62370976 62370972 62370978 62291922 62370979 62370973 62370990 62326104

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 7 of 48

VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Z-1020-2018

Recall number: Z-1020-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-013-11 Lot Numbers: 61879448 61768680 77000811 Item Number: 00-7843-013-12 Lot Numbers: 62029061 61852818 62116481 61937672 62143765

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 8 of 48

VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Z-1021-2018

Recall number: Z-1021-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-015-11 Lot Numbers: 62097294 11006832 62116495 61981821 Item Number: 00-7843-015-12 Lot Numbers: 62085294 11004177 62097244 61759259 62133149 61807097 77000821 61963730

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 9 of 48

VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Z-1022-2018

Recall number: Z-1022-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-012-56 Lot Numbers: 62089495 11007679 62097295

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 10 of 48

VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Z-1023-2018

Recall number: Z-1023-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-013-56 Lot Numbers: 61993635 61987936 62011961 Item Number: 00-7843-013-06 Lot Numbers: 61721714 62097225

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 11 of 48

VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Z-1024-2018

Recall number: Z-1024-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-014-26 Lot Number: 61741806 Item Number: 00-7843-014-06 Lot Numbers: 61886028 61752736 62120676

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 12 of 48

VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Z-1025-2018

Recall number: Z-1025-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-015-06 Lot Numbers: 11004305 61729918

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 13 of 48

VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Z-1026-2018

Recall number: Z-1026-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-012-36 Lot Number: 62132189 Item Number: 00-7843-013-36 Lot Numbers: 62085292 62120673 Item Number: 00-7843-015-36 Lot Numbers: 61695988 62089503 Item Number: 00-7843-017-36 Lot Number: 62097290

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 14 of 48

VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Z-1027-2018

Recall number: Z-1027-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-013-07 Lot Numbers: 61946025 61735805 61993658 61768679 62029060 61815080 62043103 61879441 77000599 Item Number: 00-7843-015-07 Lot Number: 62135320 Item Number: 00-7843-016-17 Lot Numbers: 61879439 61993648

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 15 of 48

VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Z-1028-2018

Recall number: Z-1028-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-013-18 Lot Number: 62158840

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 16 of 48

VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Z-1029-2018

Recall number: Z-1029-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 00-7843-012-08 Lot Numbers: 62053685 62116471 Item Number: 00-7843-013-08 Lot Number: 62184774 Item Number: 00-7843-014-08 Lot Numbers: 62184777 62158847 62184778 Item Number: 00-7843-013-81 Lot Numbers: 61987954 61815082 62116484 61956726 Item Number: 00-7843-015-08 Lot Number: 62158851 Item Number: 00-7843-013-82 Lot Numbers: 61937673 61759258 61951276 61815083 62120674 61829373 77000819 Item Number: 00-7843-015-81 Lot Numbers: 61968101 61781981 61968103 Item Number: 00-7843-015-82 Lot Numbers: 61834826 61932605 Item Number: 00-7843-016-81 Lot Numbers: 61735809 61759260 Item Number: 00-7843-016-82 Lot Numbers: 62029071 61775246 62029071N 61981820 77000820

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 17 of 48

CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis

Z-1030-2018

Recall number: Z-1030-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

Item Number: 65-5972-015-01 Lot Number: 62086845 Item Number: 65-5972-016-01 Lot Numbers: 11007043 62105229

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 18 of 48

CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HATCP FEM F-L MINUS CR-FLX POR HATCP FEM F-R MINUS CR-FLX POR HATCP FEM G-L MINUS CR-FLX POR HATCP FEM G-R MINUS This device is indicated for patients with severe knee pain and disability

Z-1031-2018

Recall number: Z-1031-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

65-5952-013-05 61819644 65-5952-013-05 61855471 65-5952-013-05 11004433 65-5952-013-06 62056868 65-5952-014-05 61782591 65-5952-014-05 11003623 65-5952-014-05 61987912 65-5952-014-05 62104150 65-5952-014-06 61835232 65-5952-014-06 62038826 65-5952-014-06 62132128 65-5952-015-05 61782592 65-5952-015-05 61822359 65-5952-015-05 61857405 65-5952-015-05 11004436 65-5952-015-05 61939607 65-5952-015-05 62020177 65-5952-015-05 62046101 65-5952-015-05 62122758 65-5952-015-06 61805662 65-5952-015-06 11003505 65-5952-015-06 61848476 65-5952-015-06 11004261 65-5952-015-06 61921288 65-5952-015-06 61968654 65-5952-015-06 62001382 65-5952-015-06 62025672 65-5952-015-06 62074886 65-5952-015-06 62128161 65-5952-016-05 61801433 65-5952-016-05 61836563 65-5952-016-05 61857407 65-5952-016-05 11004258 65-5952-016-05 11004438 65-5952-016-05 61928636 65-5952-016-05 61951539 65-5952-016-05 62020178 65-5952-016-05 62056869 65-5952-016-05 62092424 65-5952-016-05 62139313 65-5952-016-06 61777547 65-5952-016-06 61822354 65-5952-016-06 61857408 65-5952-016-06 11004434 65-5952-016-06 61904112 65-5952-016-06 61939609 65-5952-016-06 62002454 65-5952-016-06 62020219 65-5952-016-06 62062056 65-5952-016-06 62104151 65-5952-017-05 61824510 65-5952-017-05 61893908 65-5952-017-05 61939612 65-5952-017-05 62005729 65-5952-017-05 62025675 65-5952-017-05 62086012 65-5952-017-05 62132131 65-5952-017-06 11003018 65-5952-017-06 61795937 65-5952-017-06 61822355 65-5952-017-06 11003671 65-5952-017-06 61861698 65-5952-017-06 61846121 65-5952-017-06 11004260 65-5952-017-06 61915980 65-5952-017-06 61987914 65-5952-017-06 62020182 65-5952-017-06 62038827 65-5952-017-06 62105368

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 19 of 48

CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This device is indicated for patients with severe knee pain and disability

Z-1032-2018

Recall number: Z-1032-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

65-5952-013-01 62020175 65-5952-013-02 62038825 65-5952-013-02 62110571 65-5952-014-01 61782590 65-5952-014-01 61815515 65-5952-014-01 61846120 65-5952-014-01 61855468 65-5952-014-01 61866624 65-5952-014-01 11004583 65-5952-014-01 61987911 65-5952-014-01 62020176 65-5952-014-01 62046099 65-5952-014-01 62068159 65-5952-014-01 62117121 65-5952-014-02 61822350 65-5952-014-02 61848475 65-5952-014-02 61899497 65-5952-014-02 61974938 65-5952-014-02 62013405 65-5952-014-02 62032575 65-5952-014-02 62068160 65-5952-014-02 62110572 65-5952-014-02 62139310 65-5952-015-01 61801431 65-5952-015-01 61822351 65-5952-015-01 61831562 65-5952-015-01 61855469 65-5952-015-01 61861694 65-5952-015-01 11004349 65-5952-015-01 11004533 65-5952-015-01 61910510 65-5952-015-01 61949553 65-5952-015-01 61936668 65-5952-015-01 61994913 65-5952-015-01 11005729 65-5952-015-01 62005727 65-5952-015-01 62025668 65-5952-015-01 62025669 65-5952-015-01 11006459 65-5952-015-01 62054539 65-5952-015-01 62074885 65-5952-015-01 11006641 65-5952-015-01 62092422 65-5952-015-01 62117122 65-5952-015-01 62139311 65-5952-015-02 61789012 65-5952-015-02 61801432 65-5952-015-02 61822358 65-5952-015-02 61831563 65-5952-015-02 61861695 65-5952-015-02 61836562 65-5952-015-02 11004148 65-5952-015-02 11004348 65-5952-015-02 11004504 65-5952-015-02 61910511 65-5952-015-02 61936669 65-5952-015-02 61949554 65-5952-015-02 61968653 65-5952-015-02 62013406 65-5952-015-02 62025670 65-5952-015-02 62025671 65-5952-015-02 62062054 65-5952-015-02 62080588 65-5952-015-02 62105374 65-5952-015-02 11007056 65-5952-015-02 62110573 65-5952-015-02 62139312 65-5952-016-01 61777546 65-5952-016-01 61795935 65-5952-016-01 61805663 65-5952-016-01 11003498 65-5952-016-01 61822352 65-5952-016-01 61824508 65-5952-016-01 61848477 65-5952-016-01 61857406 65-5952-016-01 61866625 65-5952-016-01 11004357 65-5952-016-01 11004435 65-5952-016-01 61915979 65-5952-016-01 61935649 65-5952-016-01 61949555 65-5952-016-01 61951537 65-5952-016-01 62001383 65-5952-016-01 62013407 65-5952-016-01 62025673 65-5952-016-01 62020217 65-5952-016-01 11006442 65-5952-016-01 62046102 65-5952-016-01 62054540 65-5952-016-01 62080589 65-5952-016-01 62092423 65-5952-016-01 62117123 65-5952-016-02 61774128 65-5952-016-02 61789013 65-5952-016-02 61815516 65-5952-016-02 61822353 65-5952-016-02 61831564 65-5952-016-02 61848478 65-5952-016-02 61855470 65-5952-016-02 61861696 65-5952-016-02 11004351 65-5952-016-02 11004432 65-5952-016-02 61899498 65-5952-016-02 11004505 65-5952-016-02 61928637 65-5952-016-02 61939608 65-5952-016-02 61951538 65-5952-016-02 62001384 65-5952-016-02 62013408 65-5952-016-02 62020218 65-5952-016-02 62032576 65-5952-016-02 62062055 65-5952-016-02 62068161 65-5952-016-02 62086793 65-5952-016-02 62105375 65-5952-016-02 62128162 65-5952-016-02 62117124 65-5952-017-01 61777548 65-5952-017-01 61795936 65-5952-017-01 61815517 65-5952-017-01 61824509 65-5952-017-01 61836564 65-5952-017-01 11004091 65-5952-017-01 61857409 65-5952-017-01 11004205 65-5952-017-01 61861697 65-5952-017-01 61885032 65-5952-017-01 11004582 65-5952-017-01 61921289 65-5952-017-01 61939610 65-5952-017-01 61949556 65-5952-017-01 11005728 65-5952-017-01 61983388 65-5952-017-01 61994915 65-5952-017-01 62013409 65-5952-017-01 62020181 65-5952-017-01 62032577 65-5952-017-01 62054542 65-5952-017-01 62074887 65-5952-017-01 62086794 65-5952-017-01 62110574 65-5952-017-01 62128163 65-5952-017-02 61789014 65-5952-017-02 61805664 65-5952-017-02 61822360 65-5952-017-02 61836565 65-5952-017-02 61857410 65-5952-017-02 61866626 65-5952-017-02 11004506 65-5952-017-02 11004666 65-5952-017-02 61904113 65-5952-017-02 61935650 65-5952-017-02 61951540 65-5952-017-02 61939611 65-5952-017-02 61987913 65-5952-017-02 11006037 65-5952-017-02 62005728 65-5952-017-02 62025674 65-5952-017-02 62020179 65-5952-017-02 62056871 65-5952-017-02 62068162 65-5952-017-02 62086795 65-5952-017-02 62104152 65-5952-017-02 62122759 65-5952-017-02 62132130 00-5750-013-01 61951107 00-5750-013-01 61990633 00-5750-013-01 62003770 00-5750-013-01 62088332 00-5750-013-01 62168463 00-5750-013-02 61970680 00-5750-013-02 62004806 00-5750-013-02 62093265 00-5750-013-02 62166656 00-5750-014-01 61827938 00-5750-014-01 11400140 00-5750-014-01 61844939 00-5750-014-01 61879304 00-5750-014-01 11400196 00-5750-014-01 61905173 00-5750-014-01 61929402 00-5750-014-01 61951674 00-5750-014-01 61964632 00-5750-014-01 61972167 00-5750-014-01 62004808 00-5750-014-01 62029480 00-5750-014-01 62072208 00-5750-014-01 62087759 00-5750-014-01 62093268 00-5750-014-01 62121194 00-5750-014-01 62134274 00-5750-014-01 62159864 00-5750-014-01 62170341 00-5750-014-01 62170342 00-5750-014-01 62170343 00-5750-014-02 61791935 00-5750-014-02 61791936 00-5750-014-02 61813666 00-5750-014-02 11400111 00-5750-014-02 61843131 00-5750-014-02 61862167 00-5750-014-02 61870724 00-5750-014-02 61890017 00-5750-014-02 61905264 00-5750-014-02 61914484 00-5750-014-02 61951689 00-5750-014-02 61970681 00-5750-014-02 61978269 00-5750-014-02 61990915 00-5750-014-02 62011560 00-5750-014-02 62022989 00-5750-014-02 62059374 00-5750-014-02 62072514 00-5750-014-02 62088280 00-5750-014-02 62093271 00-5750-014-02 62132082 00-5750-014-02 62134707 00-5750-014-02 62159269 00-5750-014-02 62170344 00-5750-014-02 62170384 00-5750-014-02 62171084 00-5750-015-01 61797750 00-5750-015-01 61804265 00-5750-015-01 61809715 00-5750-015-01 61810409 00-5750-015-01 61819936 00-5750-015-01 61820642 00-5750-015-01 61829061 00-5750-015-01 61834876 00-5750-015-01 61842352 00-5750-015-01 61847666 00-5750-015-01 61863943 00-5750-015-01 61870821 00-5750-015-01 61878293 00-5750-015-01 61889443 00-5750-015-01 61895335 00-5750-015-01 11400226 00-5750-015-01 61902970 00-5750-015-01 61905209 00-5750-015-01 61909358 00-5750-015-01 61908315 00-5750-015-01 61916173 00-5750-015-01 61916174 00-5750-015-01 61921446 00-5750-015-01 61931666 00-5750-015-01 61941604 00-5750-015-01 61952956 00-5750-015-01 61958754 00-5750-015-01 61963888 00-5750-015-01 61966239 00-5750-015-01 61966240 00-5750-015-01 61979149 00-5750-015-01 61986108 00-5750-015-01 61996141 00-5750-015-01 62002081 00-5750-015-01 62002082 00-5750-015-01 62011329 00-5750-015-01 62018053 00-5750-015-01 62018142 00-5750-015-01 62028178 00-5750-015-01 62029873 00-5750-015-01 62029875 00-5750-015-01 62035840 00-5750-015-01 62042331 00-5750-015-01 62049388 00-5750-015-01 62055039 00-5750-015-01 62060477 00-5750-015-01 62064338 00-5750-015-01 62086643 00-5750-015-01 62091506 00-5750-015-01 62091507 00-5750-015-01 62086644 00-5750-015-01 62106697 00-5750-015-01 62116013 00-5750-015-01 62121558 00-5750-015-01 62121556 00-5750-015-01 62132523 00-5750-015-01 62132525 00-5750-015-01 62140119 00-5750-015-01 62148243 00-5750-015-01 62152391 00-5750-015-01 62155453 00-5750-015-01 62170954 00-5750-015-01 62170955 00-5750-015-01 62170956 00-5750-015-01 62170957 00-5750-015-01 62170958 00-5750-015-01 62172733 00-5750-015-01 62172742 00-5750-015-01 62172749 00-5750-015-01 62172737 00-5750-015-01 62172750 00-5750-015-02 61794716 00-5750-015-02 61810412 00-5750-015-02 61811776 00-5750-015-02 61820645 00-5750-015-02 61824008 00-5750-015-02 61834877 00-5750-015-02 61838758 00-5750-015-02 61847670 00-5750-015-02 61862132 00-5750-015-02 61872331 00-5750-015-02 61876301 00-5750-015-02 61879242 00-5750-015-02 61885147 00-5750-015-02 61886280 00-5750-015-02 61890706 00-5750-015-02 61890043 00-5750-015-02 61904206 00-5750-015-02 61910227 00-5750-015-02 61910229 00-5750-015-02 61910889 00-5750-015-02 61918992 00-5750-015-02 61923590 00-5750-015-02 61936794 00-5750-015-02 61950709 00-5750-015-02 61950710 00-5750-015-02 61960710 00-5750-015-02 61964117 00-5750-015-02 61970682 00-5750-015-02 61973267 00-5750-015-02 61986430 00-5750-015-02 61986739 00-5750-015-02 61996356 00-5750-015-02 61996357 00-5750-015-02 62011576 00-5750-015-02 62011577 00-5750-015-02 62011578 00-5750-015-02 62011579 00-5750-015-02 62022109 00-5750-015-02 62020823 00-5750-015-02 62028437 00-5750-015-02 62033069 00-5750-015-02 62036622 00-5750-015-02 62043322 00-5750-015-02 62050766 00-5750-015-02 62060528 00-5750-015-02 62071255 00-5750-015-02 62075660 00-5750-015-02 62079865 00-5750-015-02 62087941 00-5750-015-02 62092277 00-5750-015-02 62094385 00-5750-015-02 62106698 00-5750-015-02 62107126 00-5750-015-02 62117325 00-5750-015-02 62121774 00-5750-015-02 62132865 00-5750-015-02 62132878 00-5750-015-02 62141732 00-5750-015-02 62141927 00-5750-015-02 62147818 00-5750-015-02 62152394 00-5750-015-02 62156825 00-5750-015-02 62166658 00-5750-015-02 62166748 00-5750-015-02 62171101 00-5750-015-02 62171102 00-5750-015-02 62171757 00-5750-015-02 62171762 00-5750-015-02 62171764 00-5750-015-02 62173170 00-5750-016-01 61794718 00-5750-016-01 61796369 00-5750-016-01 61804735 00-5750-016-01 61823887 00-5750-016-01 61834861 00-5750-016-01 61843134 00-5750-016-01 61879330 00-5750-016-01 61886333 00-5750-016-01 61890709 00-5750-016-01 61905190 00-5750-016-01 61905191 00-5750-016-01 61914487 00-5750-016-01 61929422 00-5750-016-01 61936004 00-5750-016-01 61946957 00-5750-016-01 61955579 00-5750-016-01 61962742 00-5750-016-01 61962744 00-5750-016-01 61976418 00-5750-016-01 61982466 00-5750-016-01 61996959 00-5750-016-01 62005925 00-5750-016-01 62007016 00-5750-016-01 62013511 00-5750-016-01 62022325 00-5750-016-01 62022324 00-5750-016-01 62034567 00-5750-016-01 62044626 00-5750-016-01 62063739 00-5750-016-01 62072219 00-5750-016-01 62080345 00-5750-016-01 62092539 00-5750-016-01 62093019 00-5750-016-01 62112670 00-5750-016-01 62119497 00-5750-016-01 62125812 00-5750-016-01 62137994 00-5750-016-01 62144301 00-5750-016-01 62152969 00-5750-016-01 62155068 00-5750-016-01 62171793 00-5750-016-02 61796371 00-5750-016-02 61798627 00-5750-016-02 61809722 00-5750-016-02 61819934 00-5750-016-02 61823891 00-5750-016-02 61823892 00-5750-016-02 61829840 00-5750-016-02 61844041 00-5750-016-02 61846258 00-5750-016-02 61867611 00-5750-016-02 61876284 00-5750-016-02 11400202 00-5750-016-02 61888046 00-5750-016-02 61893643 00-5750-016-02 61900478 00-5750-016-02 61905269 00-5750-016-02 61905271 00-5750-016-02 61914490 00-5750-016-02 61922259 00-5750-016-02 61936008 00-5750-016-02 61936677 00-5750-016-02 61946960 00-5750-016-02 61959246 00-5750-016-02 61959248 00-5750-016-02 11400318 00-5750-016-02 61968824 00-5750-016-02 61968857 00-5750-016-02 61976430 00-5750-016-02 61988466 00-5750-016-02 61989668 00-5750-016-02 61997351 00-5750-016-02 62005963 00-5750-016-02 62014079 00-5750-016-02 62014080 00-5750-016-02 62022326 00-5750-016-02 62022327 00-5750-016-02 62038034 00-5750-016-02 62046244 00-5750-016-02 62064361 00-5750-016-02 62073119 00-5750-016-02 62080827 00-5750-016-02 62088862 00-5750-016-02 62094391 00-5750-016-02 62106555 00-5750-016-02 62112673 00-5750-016-02 62130983 00-5750-016-02 62138093 00-5750-016-02 62146939 00-5750-016-02 62154050 00-5750-016-02 62163077 00-5750-016-02 62171794 00-5750-017-01 61830532 00-5750-017-01 61870826 00-5750-017-01 61889195 00-5750-017-01 11400212 00-5750-017-01 11400228 00-5750-017-01 61943192 00-5750-017-01 61970695 00-5750-017-01 61977555 00-5750-017-01 62003098 00-5750-017-01 62036516 00-5750-017-01 62075677 00-5750-017-01 62134276 00-5750-017-01 62164340 00-5750-017-01 62172421 00-5750-017-02 61830533 00-5750-017-02 61870831 00-5750-017-02 61890024 00-5750-017-02 61904207 00-5750-017-02 61906387 00-5750-017-02 61926131 00-5750-017-02 61931674 00-5750-017-02 61958023 00-5750-017-02 61963893 00-5750-017-02 61984229 00-5750-017-02 62003103 00-5750-017-02 62036517 00-5750-017-02 62081907 00-5750-017-02 62091452 00-5750-017-02 62146658 00-5750-017-02 62172422

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 20 of 48

NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

Z-1033-2018

Recall number: Z-1033-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

6307-00-008 62125578 6307-00-020 61975784 6307-00-020 62098206 6307-00-030 11004845 6307-00-030 62142198 6307-00-009 62107229 6307-00-021 11004878 6307-00-021 62160819 6307-00-021 62155319 6307-00-021 62162357 6307-00-021 62164084 6307-00-021 62176798 6307-00-021 62174770 6307-00-021 62173770 6307-00-021 62177132 6307-00-021 62172373 6307-00-021 62178184 6307-00-021 62178731 6307-00-021 62183228 6307-00-021 62180483 6307-00-021 62185696 6307-00-021 62181538 6307-00-021 62188142 6307-00-021 11007719 6307-00-021 62189950 6307-00-021 62193587 6307-00-021 62190389 6307-00-021 62192798 6307-00-021 62196210 6307-00-021 62194526 6307-00-021 11007656 6307-00-021 62200791 6307-00-021 62203902 6307-00-021 62206609 6307-00-021 11007666 6307-00-021 62191204 6307-00-021 11007831 6307-00-021 11007677 6307-00-021 11007922 6307-00-021 11007925 6307-00-021 11007944 6307-00-021 62210574 6307-00-021 62208953 6307-00-021 62210107 6307-00-021 62207438 6307-00-021 11008018

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 21 of 48

LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability

Z-1034-2018

Recall number: Z-1034-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5996-018-92 61836677

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 22 of 48

LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL F-R LPS OPTION FEMORAL G-L LPS OPTION FEMORAL G-R LPS OPTION FEMORAL H-L This device is indicated for patients with severe knee pain and disability

Z-1035-2018

Recall number: Z-1035-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

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61907458 00-5996-016-02 61910876 00-5996-016-02 61910877 00-5996-016-02 61914460 00-5996-016-02 61914461 00-5996-016-02 61915323 00-5996-016-02 11400217 00-5996-016-02 61915322 00-5996-016-02 61918954 00-5996-016-02 61918955 00-5996-016-02 61918953 00-5996-016-02 61918956 00-5996-016-02 11400222 00-5996-016-02 61923581 00-5996-016-02 61923582 00-5996-016-02 61924456 00-5996-016-02 61923580 00-5996-016-02 11400278

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 23 of 48

LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R LPS FEM COMP SZ G-L LPS FEM COMP SZ G-R This device is indicated for patients with severe knee pain and disability

Z-1036-2018

Recall number: Z-1036-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5996-012-01 00-5996-012-02 00-5996-013-01 00-5996-013-02 00-5996-013-51 00-5996-013-52 00-5996-014-01 00-5996-014-02 00-5996-014-51 00-5996-014-52 00-5996-015-01 00-5996-015-02 00-5996-015-51 00-5996-015-52 00-5996-016-01 00-5996-016-02 00-5996-016-51 00-5996-016-52 00-5996-017-01 00-5996-017-02 LOT CODES NOT PROVIDED

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 24 of 48

LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device is indicated for patients with severe knee pain and disability

Z-1037-2018

Recall number: Z-1037-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5994-013-91 61758275 00-5994-013-92 61758283 00-5994-014-92 61768114 00-5994-014-92 11004374 00-5994-014-92 11004966 00-5994-014-92 11006826 00-5994-015-91 11003022 00-5994-015-92 61771825 00-5994-015-92 61771822 00-5994-015-92 61771828 00-5994-015-92 61771826 00-5994-015-92 61771827 00-5994-016-91 61768099 00-5994-016-91 61771829 00-5994-016-91 11005670 00-5994-016-92 61768104 00-5994-016-92 61771832

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 25 of 48

LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability

Z-1038-2018

Recall number: Z-1038-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5992-017-91 61928631 00-5990-017-91 61771841

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 26 of 48

LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated for patients with severe knee pain and disability

Z-1039-2018

Recall number: Z-1039-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5990-014-31 61938548 00-5990-014-32 00-5990-015-31 00-5992-014-31 00-5992-015-31

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 27 of 48

LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability

Z-1040-2018

Recall number: Z-1040-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5990-014-02 00-5990-015-02 00-5992-016-02

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 28 of 48

CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS FEM COMP SIZE H/R This device is indicated for patients with severe knee pain and disability

Z-1041-2018

Recall number: Z-1041-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5972-015-01 61777593 00-5972-018-02 4002192 00-5970-012-02 61878272 00-5970-013-02 61777576 00-5970-013-02 62135909 00-5970-014-02 11400192 00-5970-014-02 62122787 00-5970-014-02 62135920 00-5970-014-02 62132399 00-5970-014-02 62132399R 00-5970-014-02 62135921 00-5970-015-02 11002229 00-5970-015-02 61777581 00-5970-015-02 62135936 00-5970-016-02 61777583 00-5970-016-02 62128113 00-5970-017-01 11003049 00-5970-018-01 61758971 00-5970-018-01 11003323 00-5970-018-02 11003330 00-5970-018-02 11003322

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 29 of 48

CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COMP SIZE F/R CR OPTION FEM COMP SIZE G/L CR OPTION FEM COMP SIZE G/R This device is indicated for patients with severe knee pain and disability

Z-1042-2018

Recall number: Z-1042-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5966-013-01 61893236 00-5966-013-01 61939720 00-5966-013-01 61976414 00-5966-013-01 61997338 00-5966-013-01 61997339 00-5966-013-01 62164866 00-5966-013-01 62173181 00-5966-013-02 61893622 00-5966-013-02 61939721 00-5966-013-02 61976415 00-5966-013-02 61997340 00-5966-013-02 61998618 00-5966-013-02 62142586 00-5966-013-02 62172419 00-5966-014-01 61782655 00-5966-014-01 61850922 00-5966-014-01 61855960 00-5966-014-01 61873439 00-5966-014-01 61883263 00-5966-014-01 61883264 00-5966-014-01 61886303 00-5966-014-01 61890020 00-5966-014-01 61890021 00-5966-014-01 61890694 00-5966-014-01 61896063 00-5966-014-01 61916149 00-5966-014-01 61918723 00-5966-014-01 61918967 00-5966-014-01 61924446 00-5966-014-01 61933809 00-5966-014-01 61943608 00-5966-014-01 61946984 00-5966-014-01 11400307 00-5966-014-01 61971724 00-5966-014-01 61971725 00-5966-014-01 61974122 00-5966-014-01 61974123 00-5966-014-01 61978521 00-5966-014-01 61978522 00-5966-014-01 61989037 00-5966-014-01 61996346 00-5966-014-01 61996347 00-5966-014-01 62002067 00-5966-014-01 62002068 00-5966-014-01 61988452 00-5966-014-01 62022322 00-5966-014-01 62033088 00-5966-014-01 62038014 00-5966-014-01 62047986 00-5966-014-01 62047985 00-5966-014-01 62067952 00-5966-014-01 62073104 00-5966-014-01 62080815 00-5966-014-01 62085948 00-5966-014-01 62092287 00-5966-014-01 62110232 00-5966-014-01 62110233 00-5966-014-01 62119544 00-5966-014-01 62123030 00-5966-014-01 62133158 00-5966-014-01 62139972 00-5966-014-01 62139995 00-5966-014-01 62142356 00-5966-014-01 62152617 00-5966-014-01 62152618 00-5966-014-01 62164318 00-5966-014-01 62173182 00-5966-014-02 61851720 00-5966-014-02 61874459 00-5966-014-02 61879226 00-5966-014-02 61883265 00-5966-014-02 61883266 00-5966-014-02 61893232 00-5966-014-02 61890696 00-5966-014-02 61893234 00-5966-014-02 61902949 00-5966-014-02 61916150 00-5966-014-02 61918968 00-5966-014-02 61918969 00-5966-014-02 61924447 00-5966-014-02 61933810 00-5966-014-02 61937797 00-5966-014-02 61947190 00-5966-014-02 61947191 00-5966-014-02 61971726 00-5966-014-02 61971727 00-5966-014-02 61971728 00-5966-014-02 61976416 00-5966-014-02 61977294 00-5966-014-02 61978523 00-5966-014-02 61979109 00-5966-014-02 61979116 00-5966-014-02 61989039 00-5966-014-02 61996348 00-5966-014-02 61996349 00-5966-014-02 62003769 00-5966-014-02 62003768 00-5966-014-02 62022323 00-5966-014-02 62028039 00-5966-014-02 62028045 00-5966-014-02 62033089 00-5966-014-02 62038015 00-5966-014-02 62047525 00-5966-014-02 62073105 00-5966-014-02 62081426 00-5966-014-02 62081425 00-5966-014-02 62085949 00-5966-014-02 62098790 00-5966-014-02 62105729 00-5966-014-02 62110794 00-5966-014-02 62120689 00-5966-014-02 62123033 00-5966-014-02 62133828 00-5966-014-02 62140115 00-5966-014-02 62141175 00-5966-014-02 62147815 00-5966-014-02 62152642 00-5966-014-02 62164670 00-5966-014-02 62164672 00-5966-014-02 62164822 00-5966-015-01 61788743 00-5966-015-01 61851725 00-5966-015-01 61851726 00-5966-015-01 61865917 00-5966-015-01 61874466 00-5966-015-01 61881044 00-5966-015-01 61881045 00-5966-015-01 61885779 00-5966-015-01 61886270 00-5966-015-01 61899631 00-5966-015-01 61899632 00-5966-015-01 61901222 00-5966-015-01 61907445 00-5966-015-01 61907446 00-5966-015-01 61907447 00-5966-015-01 61908303 00-5966-015-01 61908304 00-5966-015-01 61909335 00-5966-015-01 11400253 00-5966-015-01 61917749 00-5966-015-01 61918721 00-5966-015-01 61917750 00-5966-015-01 61918722 00-5966-015-01 61918970 00-5966-015-01 61917751 00-5966-015-01 61918972 00-5966-015-01 61918971 00-5966-015-01 61920436 00-5966-015-01 61924448 00-5966-015-01 61924449 00-5966-015-01 61937799 00-5966-015-01 11400295 00-5966-015-01 61942841 00-5966-015-01 61943188 00-5966-015-01 61946980 00-5966-015-01 61946975 00-5966-015-01 61964947 00-5966-015-01 61965576 00-5966-015-01 61964949 00-5966-015-01 61977306 00-5966-015-01 61977316 00-5966-015-01 61979126 00-5966-015-01 61979130 00-5966-015-01 61979774 00-5966-015-01 61979776 00-5966-015-01 11400336 00-5966-015-01 61987062 00-5966-015-01 61987063 00-5966-015-01 61996942 00-5966-015-01 61996943 00-5966-015-01 61998627 00-5966-015-01 61998629 00-5966-015-01 61998630 00-5966-015-01 62003109 00-5966-015-01 62003113 00-5966-015-01 62008742 00-5966-015-01 62008743 00-5966-015-01 62020808 00-5966-015-01 62033090 00-5966-015-01 62034603 00-5966-015-01 62034604 00-5966-015-01 62038575 00-5966-015-01 62038808 00-5966-015-01 62038572 00-5966-015-01 62040757 00-5966-015-01 62048441 00-5966-015-01 62048442 00-5966-015-01 62066772 00-5966-015-01 62074210 00-5966-015-01 62079856 00-5966-015-01 62080306 00-5966-015-01 62086629 00-5966-015-01 62086630 00-5966-015-01 62092284 00-5966-015-01 62092524 00-5966-015-01 62098791 00-5966-015-01 62098792 00-5966-015-01 62105730 00-5966-015-01 62110795 00-5966-015-01 62110809 00-5966-015-01 62110810 00-5966-015-01 62117283 00-5966-015-01 62123034 00-5966-015-01 62128363 00-5966-015-01 62128375 00-5966-015-01 62131027 00-5966-015-01 62137079 00-5966-015-01 62146937 00-5966-015-01 62155683 00-5966-015-01 62159281 00-5966-015-01 62156809 00-5966-015-01 62164823 00-5966-015-01 62171734 00-5966-015-01 62171789 00-5966-015-01 62174412 00-5966-015-01 62174413 00-5966-015-02 61782660 00-5966-015-02 61851727 00-5966-015-02 61851728 00-5966-015-02 61861361 00-5966-015-02 61865915 00-5966-015-02 61865916 00-5966-015-02 61870728 00-5966-015-02 61874467 00-5966-015-02 61879228 00-5966-015-02 61881671 00-5966-015-02 61881672 00-5966-015-02 61886323 00-5966-015-02 61886335 00-5966-015-02 61901223 00-5966-015-02 61901224 00-5966-015-02 61901225 00-5966-015-02 61902951 00-5966-015-02 61902952 00-5966-015-02 61902953 00-5966-015-02 61908284 00-5966-015-02 61908285 00-5966-015-02 61908286 00-5966-015-02 61909339 00-5966-015-02 61909480 00-5966-015-02 11400252 00-5966-015-02 61917752 00-5966-015-02 61917753 00-5966-015-02 61917754 00-5966-015-02 61918719 00-5966-015-02 61918720 00-5966-015-02 61920437 00-5966-015-02 61920439 00-5966-015-02 61920438 00-5966-015-02 61920440 00-5966-015-02 61926126 00-5966-015-02 61924450 00-5966-015-02 61939184 00-5966-015-02 61939185 00-5966-015-02 61939182 00-5966-015-02 61946981 00-5966-015-02 61946982 00-5966-015-02 61961808 00-5966-015-02 61961809 00-5966-015-02 61962865 00-5966-015-02 61965577 00-5966-015-02 61965934 00-5966-015-02 61965935 00-5966-015-02 61977550 00-5966-015-02 61977551 00-5966-015-02 61977552 00-5966-015-02 61982743 00-5966-015-02 61982744 00-5966-015-02 61983003 00-5966-015-02 61983004 00-5966-015-02 61988191 00-5966-015-02 61988194 00-5966-015-02 61991759 00-5966-015-02 61991760 00-5966-015-02 11400352 00-5966-015-02 61998807 00-5966-015-02 61998808 00-5966-015-02 62003609 00-5966-015-02 62003615 00-5966-015-02 62008746 00-5966-015-02 62008747 00-5966-015-02 62008744 00-5966-015-02 62020809 00-5966-015-02 62028447 00-5966-015-02 62028080 00-5966-015-02 62028084 00-5966-015-02 62038814 00-5966-015-02 62040758 00-5966-015-02 62039938 00-5966-015-02 62040759 00-5966-015-02 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Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 30 of 48

LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION FEMORAL F-L LPS-FLEX OPTION FEMORAL F-R LPS-FLEX OPTION FEMORAL G-L LPS-FLEX OPTION FEMORAL G-R This device is indicated for patients with severe knee pain and disability

Z-1043-2018

Recall number: Z-1043-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

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Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 31 of 48

LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX PRECOAT FEMORAL G-L LPS-FLEX PRECOAT FEMORAL G-R LPS-FLEX PRECOAT FEMORAL H-L LPS-FLEX PRECOAT FEMORAL H-R¿ LPS-FLEX POROUS FEMORAL E-R This device is indicated for patients with severe knee pain and disability¿

Z-1044-2018

Recall number: Z-1044-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

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00-5950-016-01 62131228 00-5950-016-01 62138328 00-5950-016-01 62138329 00-5950-016-01 62149041 00-5950-016-01 62154070 00-5950-016-01 62163074 00-5950-016-01 62170901 00-5950-016-01 62170899 00-5950-016-05 61819051 00-5950-016-05 61822951 00-5950-016-05 11400161 00-5950-016-05 61876285 00-5950-016-05 61904193 00-5950-016-05 61953104 00-5950-016-05 61958321 00-5950-016-05 62009314 00-5950-016-05 62014089 00-5950-016-05 62024313 00-5950-016-05 62090142 00-5950-016-05 62098060 00-5950-016-05 62124282 00-5950-016-05 62145401 00-5950-016-05 62170902 00-5950-016-02 11002977 00-5950-016-02 61791939 00-5950-016-02 61806298 00-5950-016-02 61808808 00-5950-016-02 11400105 00-5950-016-02 61821420 00-5950-016-02 61822949 00-5950-016-02 61822950 00-5950-016-02 11400114 00-5950-016-02 61824770 00-5950-016-02 61824771 00-5950-016-02 61829843 00-5950-016-02 61829842 00-5950-016-02 61830371 00-5950-016-02 61830372 00-5950-016-02 61844234 00-5950-016-02 61854819 00-5950-016-02 61860220 00-5950-016-02 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00-5950-016-02 62024959 00-5950-016-02 62029864 00-5950-016-02 62030343 00-5950-016-02 62039976 00-5950-016-02 62043146 00-5950-016-02 62055077 00-5950-016-02 62059367 00-5950-016-02 62065378 00-5950-016-02 62068499 00-5950-016-02 62078472 00-5950-016-02 62077295 00-5950-016-02 62088635 00-5950-016-02 62098516 00-5950-016-02 62098793 00-5950-016-02 62101547 00-5950-016-02 62107949 00-5950-016-02 62116018 00-5950-016-02 62116017 00-5950-016-02 62119548 00-5950-016-02 62124811 00-5950-016-02 62131841 00-5950-016-02 62138683 00-5950-016-02 62139369 00-5950-016-02 62149543 00-5950-016-02 62154998 00-5950-016-02 62162233 00-5950-016-02 62170048 00-5950-016-02 62170398 00-5950-016-02 62170049 00-5950-016-02 62170050 00-5950-016-02 62170399 00-5950-016-02 62169049 00-5950-016-06 61822953 00-5950-016-06 61859228 00-5950-016-06 61876286 00-5950-016-06 61903676 00-5950-016-06 61953107 00-5950-016-06 61958324 00-5950-016-06 62009315 00-5950-016-06 62024957 00-5950-016-06 62088879 00-5950-016-06 62098062 00-5950-016-06 62124283 00-5950-016-06 62162224 00-5950-016-06 62169048 00-5950-017-01 61800617 00-5950-017-01 61800616 00-5950-017-01 61814766 00-5950-017-01 61814767 00-5950-017-01 61815711 00-5950-017-01 61829065 00-5950-017-01 61829066 00-5950-017-01 61834859 00-5950-017-01 11400135 00-5950-017-01 61840473 00-5950-017-01 11400139 00-5950-017-01 61844902 00-5950-017-01 61854822 00-5950-017-01 11400156 00-5950-017-01 61860221 00-5950-017-01 61899627 00-5950-017-01 61903675 00-5950-017-01 61912355 00-5950-017-01 61918974 00-5950-017-01 61916155 00-5950-017-01 61934963 00-5950-017-01 11400282 00-5950-017-01 61936776 00-5950-017-01 61936778 00-5950-017-01 61946988 00-5950-017-01 61951696 00-5950-017-01 61950760 00-5950-017-01 11400313 00-5950-017-01 61960714 00-5950-017-01 11400317 00-5950-017-01 61960713 00-5950-017-01 61960712 00-5950-017-01 61973243 00-5950-017-01 61973244 00-5950-017-01 61980313 00-5950-017-01 61984231 00-5950-017-01 61990637 00-5950-017-01 61996360 00-5950-017-01 61996361 00-5950-017-01 11400354 00-5950-017-01 61996945 00-5950-017-01 11400357 00-5950-017-01 61999571 00-5950-017-01 62005000 00-5950-017-01 62005001 00-5950-017-01 62012670 00-5950-017-01 62018146 00-5950-017-01 62018672 00-5950-017-01 62034610 00-5950-017-01 62034607 00-5950-017-01 62038017 00-5950-017-01 62038018 00-5950-017-01 62052668 00-5950-017-01 62052669 00-5950-017-01 62060542 00-5950-017-01 62065390 00-5950-017-01 62066548 00-5950-017-01 62078824 00-5950-017-01 62078822 00-5950-017-01 62084439 00-5950-017-01 62092283 00-5950-017-01 62095239 00-5950-017-01 62102785 00-5950-017-01 62109668 00-5950-017-01 62112976 00-5950-017-01 62120702 00-5950-017-01 62125144 00-5950-017-01 62124820 00-5950-017-01 62134731 00-5950-017-01 62143173 00-5950-017-01 62154276 00-5950-017-01 62160283 00-5950-017-01 62170059 00-5950-017-01 62170392 00-5950-017-01 62170393 00-5950-017-05 61833598 00-5950-017-05 11400238 00-5950-017-05 61937290 00-5950-017-05 61960715 00-5950-017-05 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00-5950-017-02 62000987 00-5950-017-02 62005953 00-5950-017-02 62005954 00-5950-017-02 62005955 00-5950-017-02 62006741 00-5950-017-02 62006743 00-5950-017-02 62019996 00-5950-017-02 62026806 00-5950-017-02 62030596 00-5950-017-02 62036588 00-5950-017-02 62036609 00-5950-017-02 62051196 00-5950-017-02 62054065 00-5950-017-02 62060479 00-5950-017-02 62060480 00-5950-017-02 62067915 00-5950-017-02 62073089 00-5950-017-02 62086359 00-5950-017-02 62086360 00-5950-017-02 62091543 00-5950-017-02 62096011 00-5950-017-02 62096621 00-5950-017-02 62105718 00-5950-017-02 62110814 00-5950-017-02 62113002 00-5950-017-02 62113003 00-5950-017-02 62126732 00-5950-017-02 62126115 00-5950-017-02 62132540 00-5950-017-02 62135963 00-5950-017-02 62143620 00-5950-017-02 62149040 00-5950-017-02 62155001 00-5950-017-02 62160794 00-5950-017-02 62170055 00-5950-017-02 62170053 00-5950-017-06 61816389 00-5950-017-06 61917756 00-5950-017-06 61951701 00-5950-017-06 62000986 00-5950-017-06 62030646 00-5950-017-06 62067918 00-5950-017-06 62134748 00-5950-017-06 62160792 00-5950-017-06 62169050

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 32 of 48

NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability

Z-1045-2018

Recall number: Z-1045-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5962-015-52 11006115

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 33 of 48

CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FEM F-L MINUS CR-FLEX OPT FEM F-R MINUS CR-FLEX OPT FEM G-L MINUS CR-FLEX OPT FEM G-R MINUS This device is indicated for patients with severe knee pain and disability

Z-1046-2018

Recall number: Z-1046-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5956-013-06 00-5956-014-01 00-5956-014-02 00-5956-014-05 00-5956-014-06 00-5956-015-01 00-5956-015-02 00-5956-015-05 00-5956-015-06 00-5956-016-01 00-5956-016-02 00-5956-016-05 00-5956-016-06 00-5956-017-01 00-5956-017-02 00-5956-017-05 00-5956-017-06

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 34 of 48

CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L CR-FLEX OPT FEM F-R CR-FLEX OPT FEM G-L CR-FLEX OPT FEM G-R This device is indicated for patients with severe knee pain and disability

Z-1047-2018

Recall number: Z-1047-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5956-013-06 00-5956-014-01 00-5956-014-02 00-5956-014-05 00-5956-014-06 00-5956-015-01 00-5956-015-02 00-5956-015-05 00-5956-015-06 00-5956-016-01 00-5956-016-02 00-5956-016-05 00-5956-016-06 00-5956-017-01 00-5956-017-02 00-5956-017-05 00-5956-017-06

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 35 of 48

CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability

Z-1048-2018

Recall number: Z-1048-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5952-016-01 61774124 00-5952-016-01 61782595 00-5952-016-06 11004288 00-5952-017-01 11005095

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 36 of 48

CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINUS CR-FLEX PCT FEM G-L MINUS CR-FLEX PCT FEM G-R MINUS This device is indicated for patients with severe knee pain and disability

Z-1049-2018

Recall number: Z-1049-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5950-013-06 00-5950-014-01 00-5950-014-02 00-5950-014-05 00-5950-014-06 00-5950-015-01 00-5950-015-02 00-5950-015-05 00-5950-015-06 00-5950-016-01 00-5950-016-02 00-5950-016-05 00-5950-016-06 00-5950-017-01 00-5950-017-02 00-5950-017-05 00-5950-017-06

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 37 of 48

CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR-FLEX PCT FEM F-L CR-FLEX PCT FEM F-R CR-FLEX PCT FEM G-L CR-FLEX PCT FEM G-R This device is indicated for patients with severe knee pain and disability

Z-1050-2018

Recall number: Z-1050-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5950-012-02 00-5950-013-01 00-5950-013-02 00-5950-013-06 00-5950-014-01 00-5950-014-02 00-5950-014-05 00-5950-014-06 00-5950-015-01 00-5950-015-02 00-5950-015-05 00-5950-015-06 00-5950-016-01 00-5950-016-02 00-5950-016-05 00-5950-016-06 00-5950-017-01 00-5950-017-02 00-5950-017-05 00-5950-017-06

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 38 of 48

PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT MIS CR MOB PLT SZ 8 L¿ PRCT MIS CR MOB PLT SZ 8 R This device is indicated for patients with severe knee pain and disability¿

Z-1051-2018

Recall number: Z-1051-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5930-040-01 61774223 00-5930-040-01 61780003 00-5930-040-01 61774226 00-5930-040-01 61774225 00-5930-040-01 11005139 00-5930-050-01 61774236 00-5930-050-01 11004031 00-5930-060-01 61774234 00-5930-070-02 61780002 00-5930-070-01 62139076 00-5930-080-02 61774216 00-5930-080-01 61774229 00-5930-080-01 61780004 00-5930-080-02 61785662 00-5930-080-02 61774215

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 39 of 48

PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

Z-1052-2018

Recall number: Z-1052-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5926-011-01 Knee PFJ FEM, CEMENTED, SZ 1, LEFT 00-5926-012-01 Knee PFJ FEM, CEMENTED, SZ 2, LEFT 00-5926-013-01 Knee PFJ FEM, CEMENTED, SZ 3, LEFT 00-5926-013-02 Knee PFJ FEM, CEMENTED, SZ 3, RIGHT 00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT 00-5926-015-02 Knee PFJ FEM, CEMENTED, SZ 5, RIGHT

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 40 of 48

ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

Z-1053-2018

Recall number: Z-1053-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 41 of 48

ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿ ZUK PRC FEM SZD RMED/LLAT¿ ZUK PRC FEM SZE LMED/RLAT ZUK PRC FEM SZF RMED/LLAT " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Z-1054-2018

Recall number: Z-1054-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5842-012-02 61777606 00-5842-012-02 61774093 00-5842-013-01 61774095 00-5842-013-02 61777611 00-5842-014-01 11002921 00-5842-014-01 61777613 00-5842-014-02 61777615 00-5842-014-02 61777616 00-5842-015-01 61777617 00-5842-016-02 61756843

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 42 of 48

FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Z-1055-2018

Recall number: Z-1055-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5790-020-00 00-5790-021-00 00-5790-022-00 00-5790-023-00 00-5790-024-00 00-5790-025-00 00-5790-026-00 00-5790-027-00 00-5790-028-00 00-5790-029-00 00-5790-030-00 00-5790-031-00 00-5790-020-00 61855504 00-5790-020-00 11004267 00-5790-020-00 61933229 00-5790-020-00 61915949 00-5790-020-00 11005144 00-5790-020-00 61949771 00-5790-020-00 62062057 00-5790-020-00 77001776 00-5790-022-00 61788933 00-5790-022-00 61810168 00-5790-022-00 61831670 00-5790-022-00 61894364 00-5790-022-00 11004689 00-5790-022-00 61910487 00-5790-022-00 61932359 00-5790-022-00 11004850 00-5790-022-00 61939861 00-5790-022-00 61958404 00-5790-022-00 61993535 00-5790-022-00 61987879 00-5790-022-00 62041075 00-5790-022-00 62074833 00-5790-022-00 11006797 00-5790-022-00 77001778 00-5790-024-00 61788934 00-5790-024-00 61805631 00-5790-024-00 61822278 00-5790-024-00 61928510 00-5790-024-00 61952565 00-5790-024-00 62025572 00-5790-024-00 62054459 00-5790-024-00 62068114 00-5790-024-00 62080645 00-5790-024-00 62105235 00-5790-024-00 77001780 00-5790-024-00 62110658 00-5790-026-00 61777601 00-5790-026-00 61815430 00-5790-026-00 61824552 00-5790-026-00 61952567 00-5790-026-00 62005615 00-5790-026-00 11006199 00-5790-026-00 62062058 00-5790-026-00 62086067 00-5790-026-00 77001782 00-5790-028-00 61831671 00-5790-028-00 62062059 00-5790-028-00 11006735 00-5790-028-00 77001784 00-5790-030-00 61881087 00-5790-030-00 61968455 00-5790-030-00 77001786 00-5790-021-00 61933230 00-5790-021-00 11005163 00-5790-021-00 11005243 00-5790-021-00 62013359 00-5790-021-00 11006254 00-5790-021-00 62086803 00-5790-021-00 77001777 00-5790-023-00 11003416 00-5790-023-00 61795864 00-5790-023-00 11003680 00-5790-023-00 61810169 00-5790-023-00 11003843 00-5790-023-00 61889207 00-5790-023-00 61904081 00-5790-023-00 61933231 00-5790-023-00 61928509 00-5790-023-00 61949247 00-5790-023-00 61993546 00-5790-023-00 62020300 00-5790-023-00 62056497 00-5790-023-00 62074834 00-5790-023-00 77001779 00-5790-025-00 61777599 00-5790-025-00 61795865 00-5790-025-00 61822279 00-5790-025-00 61899451 00-5790-025-00 61928511 00-5790-025-00 61936678 00-5790-025-00 61952566 00-5790-025-00 11005169 00-5790-025-00 62000808 00-5790-025-00 62020301 00-5790-025-00 62056498 00-5790-025-00 62074835 00-5790-025-00 62080646 00-5790-025-00 11006839 00-5790-025-00 62104129 00-5790-025-00 77001781 00-5790-027-00 61782626 00-5790-027-00 61824553 00-5790-027-00 61921258 00-5790-027-00 61952568 00-5790-027-00 62045723 00-5790-027-00 62068115 00-5790-027-00 62092386 00-5790-027-00 77001783 00-5790-029-00 61805632 00-5790-029-00 62005616 00-5790-029-00 77001785 00-5790-031-00 62002487 00-5790-031-00 77001787

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 43 of 48

LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ E-R¿ LPS-FLEX GSK OPT SZ F-L¿ LPS-FLEX GSF OPT SZ F-R¿ LPS-FLEX GSF OPT SZ G-L¿ LPS-FLEX GSF OPT SZ G-R¿

Z-1056-2018

Recall number: Z-1056-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5764-013-51 61874481 00-5764-013-51 61892716 00-5764-013-51 61946510 00-5764-013-51 61954552 00-5764-013-51 61977566 00-5764-013-51 62003780 00-5764-013-51 62022335 00-5764-013-51 62029870 00-5764-013-51 62107937 00-5764-013-51 62121782 00-5764-013-51 62155687 00-5764-013-51 62159335 00-5764-013-52 61800630 00-5764-013-52 61808793 00-5764-013-52 61819071 00-5764-013-52 61885786 00-5764-013-52 61892717 00-5764-013-52 61914463 00-5764-013-52 61949724 00-5764-013-52 61954981 00-5764-013-52 61977567 00-5764-013-52 62003781 00-5764-013-52 62023325 00-5764-013-52 62030453 00-5764-013-52 62096017 00-5764-013-52 62102077 00-5764-013-52 62127093 00-5764-013-52 62137523 00-5764-013-52 62168360 00-5764-013-52 62169039 00-5764-013-52 62172720 00-5764-013-52 62172721 00-5764-013-52 62173154 00-5764-014-51 61793522 00-5764-014-51 61796450 00-5764-014-51 61802094 00-5764-014-51 61816554 00-5764-014-51 61817772 00-5764-014-51 61817773 00-5764-014-51 11400112 00-5764-014-51 61787880 00-5764-014-51 61829076 00-5764-014-51 61829078 00-5764-014-51 61834863 00-5764-014-51 61835849 00-5764-014-51 61842366 00-5764-014-51 61858497 00-5764-014-51 61868886 00-5764-014-51 61868887 00-5764-014-51 61881032 00-5764-014-51 61881034 00-5764-014-51 61885761 00-5764-014-51 61888051 00-5764-014-51 61892383 00-5764-014-51 61896059 00-5764-014-51 61896058 00-5764-014-51 61897301 00-5764-014-51 61902968 00-5764-014-51 61910188 00-5764-014-51 61914468 00-5764-014-51 61918704 00-5764-014-51 61918705 00-5764-014-51 61924472 00-5764-014-51 61926153 00-5764-014-51 61936817 00-5764-014-51 61943203 00-5764-014-51 61946974 00-5764-014-51 61958271 00-5764-014-51 61958748 00-5764-014-51 61965573 00-5764-014-51 61965574 00-5764-014-51 61967192 00-5764-014-51 61967194 00-5764-014-51 61974066 00-5764-014-51 61974068 00-5764-014-51 61979793 00-5764-014-51 61984251 00-5764-014-51 61986228 00-5764-014-51 61985016 00-5764-014-51 61986231 00-5764-014-51 62017272 00-5764-014-51 62023806 00-5764-014-51 62023333 00-5764-014-51 62030266 00-5764-014-51 62029858 00-5764-014-51 62030268 00-5764-014-51 62030269 00-5764-014-51 62030578 00-5764-014-51 62038009 00-5764-014-51 62038007 00-5764-014-51 62038008 00-5764-014-51 62039076 00-5764-014-51 62049410 00-5764-014-51 62049412 00-5764-014-51 62071907 00-5764-014-51 62076334 00-5764-014-51 62084449 00-5764-014-51 62085549 00-5764-014-51 62096020 00-5764-014-51 62096024 00-5764-014-51 62100483 00-5764-014-51 62100482 00-5764-014-51 62101706 00-5764-014-51 62106707 00-5764-014-51 62107956 00-5764-014-51 62110811 00-5764-014-51 62119558 00-5764-014-51 62119557 00-5764-014-51 62120493 00-5764-014-51 62131261 00-5764-014-51 62132092 00-5764-014-51 62143628 00-5764-014-51 62151117 00-5764-014-51 62151121 00-5764-014-51 62151252 00-5764-014-51 62152410 00-5764-014-51 62152412 00-5764-014-51 62162780 00-5764-014-51 62169040 00-5764-014-51 62169058 00-5764-014-51 62169061 00-5764-014-51 62169059 00-5764-014-51 62169060 00-5764-014-51 62170082 00-5764-014-51 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Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 44 of 48

NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Z-1057-2018

Recall number: Z-1057-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5762-016-52 Knee LPS-FLEX GSF POR FEM, F-R

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 45 of 48

CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MINUS¿¿ CR-FLEX GSF PCT SZ F-L MINUS¿ CR-FLEX GSF PCT SZ F-R MINUS¿ CR-FLEX GSF PCT SZ G-L MINUS¿ CR-FLEX GSF PCT SZ G-R MINUS¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Z-1058-2018

Recall number: Z-1058-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5750-013-01 00-5750-013-02 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02 00-5750-013-01 61951107 00-5750-013-01 61990633 00-5750-013-01 62003770 00-5750-013-01 62088332 00-5750-013-01 62168463 00-5750-013-02 61970680 00-5750-013-02 62004806 00-5750-013-02 62093265 00-5750-013-02 62166656 00-5750-013-06 62120693 00-5750-014-01 61827938 00-5750-014-01 11400140 00-5750-014-01 61844939 00-5750-014-01 61879304 00-5750-014-01 11400196 00-5750-014-01 61905173 00-5750-014-01 61929402 00-5750-014-01 61951674 00-5750-014-01 61964632 00-5750-014-01 61972167 00-5750-014-01 62004808 00-5750-014-01 62029480 00-5750-014-01 62072208 00-5750-014-01 62087759 00-5750-014-01 62093268 00-5750-014-01 62121194 00-5750-014-01 62134274 00-5750-014-01 62159864 00-5750-014-01 62170341 00-5750-014-01 62170342 00-5750-014-01 62170343 00-5750-014-05 62121555 00-5750-014-05 62166655 00-5750-014-02 61791935 00-5750-014-02 61791936 00-5750-014-02 61813666 00-5750-014-02 11400111 00-5750-014-02 61843131 00-5750-014-02 61862167 00-5750-014-02 61870724 00-5750-014-02 61890017 00-5750-014-02 61905264 00-5750-014-02 61914484 00-5750-014-02 61951689 00-5750-014-02 61970681 00-5750-014-02 61978269 00-5750-014-02 61990915 00-5750-014-02 62011560 00-5750-014-02 62022989 00-5750-014-02 62059374 00-5750-014-02 62072514 00-5750-014-02 62088280 00-5750-014-02 62093271 00-5750-014-02 62132082 00-5750-014-02 62134707 00-5750-014-02 62159269 00-5750-014-02 62170344 00-5750-014-02 62170384 00-5750-014-02 62171084 00-5750-014-06 62121229 00-5750-014-06 62135959 00-5750-014-06 62170385 00-5750-015-01 61797750 00-5750-015-01 61804265 00-5750-015-01 61809715 00-5750-015-01 61810409 00-5750-015-01 61819936 00-5750-015-01 61820642 00-5750-015-01 61829061 00-5750-015-01 61834876 00-5750-015-01 61842352 00-5750-015-01 61847666 00-5750-015-01 61863943 00-5750-015-01 61870821 00-5750-015-01 61878293 00-5750-015-01 61889443 00-5750-015-01 61895335 00-5750-015-01 11400226 00-5750-015-01 61902970 00-5750-015-01 61905209 00-5750-015-01 61909358 00-5750-015-01 61908315 00-5750-015-01 61916173 00-5750-015-01 61916174 00-5750-015-01 61921446 00-5750-015-01 61931666 00-5750-015-01 61941604 00-5750-015-01 61952956 00-5750-015-01 61958754 00-5750-015-01 61963888 00-5750-015-01 61966239 00-5750-015-01 61966240 00-5750-015-01 61979149 00-5750-015-01 61986108 00-5750-015-01 61996141 00-5750-015-01 62002081 00-5750-015-01 62002082 00-5750-015-01 62011329 00-5750-015-01 62018053 00-5750-015-01 62018142 00-5750-015-01 62028178 00-5750-015-01 62029873 00-5750-015-01 62029875 00-5750-015-01 62035840 00-5750-015-01 62042331 00-5750-015-01 62049388 00-5750-015-01 62055039 00-5750-015-01 62060477 00-5750-015-01 62064338 00-5750-015-01 62086643 00-5750-015-01 62091506 00-5750-015-01 62091507 00-5750-015-01 62086644 00-5750-015-01 62106697 00-5750-015-01 62116013 00-5750-015-01 62121558 00-5750-015-01 62121556 00-5750-015-01 62132523 00-5750-015-01 62132525 00-5750-015-01 62140119 00-5750-015-01 62148243 00-5750-015-01 62152391 00-5750-015-01 62155453 00-5750-015-01 62170954 00-5750-015-01 62170955 00-5750-015-01 62170956 00-5750-015-01 62170957 00-5750-015-01 62170958 00-5750-015-01 62172733 00-5750-015-01 62172742 00-5750-015-01 62172749 00-5750-015-01 62172737 00-5750-015-01 62172750 00-5750-015-05 61829059 00-5750-015-05 61979151 00-5750-015-05 62003579 00-5750-015-05 62075016 00-5750-015-05 62122660 00-5750-015-05 62133157 00-5750-015-05 62170401 00-5750-015-02 61794716 00-5750-015-02 61810412 00-5750-015-02 61811776 00-5750-015-02 61820645 00-5750-015-02 61824008 00-5750-015-02 61834877 00-5750-015-02 61838758 00-5750-015-02 61847670 00-5750-015-02 61862132 00-5750-015-02 61872331 00-5750-015-02 61876301 00-5750-015-02 61879242 00-5750-015-02 61885147 00-5750-015-02 61886280 00-5750-015-02 61890706 00-5750-015-02 61890043 00-5750-015-02 61904206 00-5750-015-02 61910227 00-5750-015-02 61910229 00-5750-015-02 61910889 00-5750-015-02 61918992 00-5750-015-02 61923590 00-5750-015-02 61936794 00-5750-015-02 61950709 00-5750-015-02 61950710 00-5750-015-02 61960710 00-5750-015-02 61964117 00-5750-015-02 61970682 00-5750-015-02 61973267 00-5750-015-02 61986430 00-5750-015-02 61986739 00-5750-015-02 61996356 00-5750-015-02 61996357 00-5750-015-02 62011576 00-5750-015-02 62011577 00-5750-015-02 62011578 00-5750-015-02 62011579 00-5750-015-02 62022109 00-5750-015-02 62020823 00-5750-015-02 62028437 00-5750-015-02 62033069 00-5750-015-02 62036622 00-5750-015-02 62043322 00-5750-015-02 62050766 00-5750-015-02 62060528 00-5750-015-02 62071255 00-5750-015-02 62075660 00-5750-015-02 62079865 00-5750-015-02 62087941 00-5750-015-02 62092277 00-5750-015-02 62094385 00-5750-015-02 62106698 00-5750-015-02 62107126 00-5750-015-02 62117325 00-5750-015-02 62121774 00-5750-015-02 62132865 00-5750-015-02 62132878 00-5750-015-02 62141732 00-5750-015-02 62141927 00-5750-015-02 62147818 00-5750-015-02 62152394 00-5750-015-02 62156825 00-5750-015-02 62166658 00-5750-015-02 62166748 00-5750-015-02 62171101 00-5750-015-02 62171102 00-5750-015-02 62171757 00-5750-015-02 62171762 00-5750-015-02 62171764 00-5750-015-02 62173170 00-5750-015-06 61797739 00-5750-015-06 61830366 00-5750-015-06 62003582 00-5750-015-06 62091562 00-5750-015-06 62122538 00-5750-015-06 62141936 00-5750-016-01 61794718 00-5750-016-01 61796369 00-5750-016-01 61804735 00-5750-016-01 61823887 00-5750-016-01 61834861 00-5750-016-01 61843134 00-5750-016-01 61879330 00-5750-016-01 61886333 00-5750-016-01 61890709 00-5750-016-01 61905190 00-5750-016-01 61905191 00-5750-016-01 61914487 00-5750-016-01 61929422 00-5750-016-01 61936004 00-5750-016-01 61946957 00-5750-016-01 61955579 00-5750-016-01 61962742 00-5750-016-01 61962744 00-5750-016-01 61976418 00-5750-016-01 61982466 00-5750-016-01 61996959 00-5750-016-01 62005925 00-5750-016-01 62007016 00-5750-016-01 62013511 00-5750-016-01 62022325 00-5750-016-01 62022324 00-5750-016-01 62034567 00-5750-016-01 62044626 00-5750-016-01 62063739 00-5750-016-01 62072219 00-5750-016-01 62080345 00-5750-016-01 62092539 00-5750-016-01 62093019 00-5750-016-01 62112670 00-5750-016-01 62119497 00-5750-016-01 62125812 00-5750-016-01 62137994 00-5750-016-01 62144301 00-5750-016-01 62152969 00-5750-016-01 62155068 00-5750-016-01 62171793 00-5750-016-05 61836353 00-5750-016-05 61970691 00-5750-016-05 11006472 00-5750-016-05 62093021 00-5750-016-05 62100379 00-5750-016-05 62126817 00-5750-016-02 61796371 00-5750-016-02 61798627 00-5750-016-02 61809722 00-5750-016-02 61819934 00-5750-016-02 61823891 00-5750-016-02 61823892 00-5750-016-02 61829840 00-5750-016-02 61844041 00-5750-016-02 61846258 00-5750-016-02 61867611 00-5750-016-02 61876284 00-5750-016-02 11400202 00-5750-016-02 61888046 00-5750-016-02 61893643 00-5750-016-02 61900478 00-5750-016-02 61905269 00-5750-016-02 61905271 00-5750-016-02 61914490 00-5750-016-02 61922259 00-5750-016-02 61936008 00-5750-016-02 61936677 00-5750-016-02 61946960 00-5750-016-02 61959246 00-5750-016-02 61959248 00-5750-016-02 11400318 00-5750-016-02 61968824 00-5750-016-02 61968857 00-5750-016-02 61976430 00-5750-016-02 61988466 00-5750-016-02 61989668 00-5750-016-02 61997351 00-5750-016-02 62005963 00-5750-016-02 62014079 00-5750-016-02 62014080 00-5750-016-02 62022326 00-5750-016-02 62022327 00-5750-016-02 62038034 00-5750-016-02 62046244 00-5750-016-02 62064361 00-5750-016-02 62073119 00-5750-016-02 62080827 00-5750-016-02 62088862 00-5750-016-02 62094391 00-5750-016-02 62106555 00-5750-016-02 62112673 00-5750-016-02 62130983 00-5750-016-02 62138093 00-5750-016-02 62146939 00-5750-016-02 62154050 00-5750-016-02 62163077 00-5750-016-02 62171794 00-5750-016-06 61843136 00-5750-016-06 61982989 00-5750-016-06 62007752 00-5750-016-06 62094390 00-5750-016-06 62138249 00-5750-017-01 61830532 00-5750-017-01 61870826 00-5750-017-01 61889195 00-5750-017-01 11400212 00-5750-017-01 11400228 00-5750-017-01 61943192 00-5750-017-01 61970695 00-5750-017-01 61977555 00-5750-017-01 62003098 00-5750-017-01 62036516 00-5750-017-01 62075677 00-5750-017-01 62134276 00-5750-017-01 62164340 00-5750-017-01 62172421 00-5750-017-05 62134278 00-5750-017-02 61830533 00-5750-017-02 61870831 00-5750-017-02 61890024 00-5750-017-02 61904207 00-5750-017-02 61906387 00-5750-017-02 61926131 00-5750-017-02 61931674 00-5750-017-02 61958023 00-5750-017-02 61963893 00-5750-017-02 61984229 00-5750-017-02 62003103 00-5750-017-02 62036517 00-5750-017-02 62081907 00-5750-017-02 62091452 00-5750-017-02 62146658 00-5750-017-02 62172422 00-5750-017-06 62134277 00-5750-017-06 62173183

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 46 of 48

CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿ CR-FLEX GSF PRECOAT SZ E-R¿ CR-FLEX GSF PRECOAT SZ F-L¿ CR-FLEX GSF PRECOAT SZ F-R¿ CR-FLEX GSF PRECOAT SZ G-L¿ CR-FLEX GSK PRECOAT SZ G-R¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Z-1059-2018

Recall number: Z-1059-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5750-013-01 00-5750-013-02 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02 00-5750-013-01 61951107 00-5750-013-01 61990633 00-5750-013-01 62003770 00-5750-013-01 62088332 00-5750-013-01 62168463 00-5750-013-02 61970680 00-5750-013-02 62004806 00-5750-013-02 62093265 00-5750-013-02 62166656 00-5750-013-06 62120693 00-5750-014-01 61827938 00-5750-014-01 11400140 00-5750-014-01 61844939 00-5750-014-01 61879304 00-5750-014-01 11400196 00-5750-014-01 61905173 00-5750-014-01 61929402 00-5750-014-01 61951674 00-5750-014-01 61964632 00-5750-014-01 61972167 00-5750-014-01 62004808 00-5750-014-01 62029480 00-5750-014-01 62072208 00-5750-014-01 62087759 00-5750-014-01 62093268 00-5750-014-01 62121194 00-5750-014-01 62134274 00-5750-014-01 62159864 00-5750-014-01 62170341 00-5750-014-01 62170342 00-5750-014-01 62170343 00-5750-014-05 62121555 00-5750-014-05 62166655 00-5750-014-02 61791935 00-5750-014-02 61791936 00-5750-014-02 61813666 00-5750-014-02 11400111 00-5750-014-02 61843131 00-5750-014-02 61862167 00-5750-014-02 61870724 00-5750-014-02 61890017 00-5750-014-02 61905264 00-5750-014-02 61914484 00-5750-014-02 61951689 00-5750-014-02 61970681 00-5750-014-02 61978269 00-5750-014-02 61990915 00-5750-014-02 62011560 00-5750-014-02 62022989 00-5750-014-02 62059374 00-5750-014-02 62072514 00-5750-014-02 62088280 00-5750-014-02 62093271 00-5750-014-02 62132082 00-5750-014-02 62134707 00-5750-014-02 62159269 00-5750-014-02 62170344 00-5750-014-02 62170384 00-5750-014-02 62171084 00-5750-014-06 62121229 00-5750-014-06 62135959 00-5750-014-06 62170385 00-5750-015-01 61797750 00-5750-015-01 61804265 00-5750-015-01 61809715 00-5750-015-01 61810409 00-5750-015-01 61819936 00-5750-015-01 61820642 00-5750-015-01 61829061 00-5750-015-01 61834876 00-5750-015-01 61842352 00-5750-015-01 61847666 00-5750-015-01 61863943 00-5750-015-01 61870821 00-5750-015-01 61878293 00-5750-015-01 61889443 00-5750-015-01 61895335 00-5750-015-01 11400226 00-5750-015-01 61902970 00-5750-015-01 61905209 00-5750-015-01 61909358 00-5750-015-01 61908315 00-5750-015-01 61916173 00-5750-015-01 61916174 00-5750-015-01 61921446 00-5750-015-01 61931666 00-5750-015-01 61941604 00-5750-015-01 61952956 00-5750-015-01 61958754 00-5750-015-01 61963888 00-5750-015-01 61966239 00-5750-015-01 61966240 00-5750-015-01 61979149 00-5750-015-01 61986108 00-5750-015-01 61996141 00-5750-015-01 62002081 00-5750-015-01 62002082 00-5750-015-01 62011329 00-5750-015-01 62018053 00-5750-015-01 62018142 00-5750-015-01 62028178 00-5750-015-01 62029873 00-5750-015-01 62029875 00-5750-015-01 62035840 00-5750-015-01 62042331 00-5750-015-01 62049388 00-5750-015-01 62055039 00-5750-015-01 62060477 00-5750-015-01 62064338 00-5750-015-01 62086643 00-5750-015-01 62091506 00-5750-015-01 62091507 00-5750-015-01 62086644 00-5750-015-01 62106697 00-5750-015-01 62116013 00-5750-015-01 62121558 00-5750-015-01 62121556 00-5750-015-01 62132523 00-5750-015-01 62132525 00-5750-015-01 62140119 00-5750-015-01 62148243 00-5750-015-01 62152391 00-5750-015-01 62155453 00-5750-015-01 62170954 00-5750-015-01 62170955 00-5750-015-01 62170956 00-5750-015-01 62170957 00-5750-015-01 62170958 00-5750-015-01 62172733 00-5750-015-01 62172742 00-5750-015-01 62172749 00-5750-015-01 62172737 00-5750-015-01 62172750 00-5750-015-05 61829059 00-5750-015-05 61979151 00-5750-015-05 62003579 00-5750-015-05 62075016 00-5750-015-05 62122660 00-5750-015-05 62133157 00-5750-015-05 62170401 00-5750-015-02 61794716 00-5750-015-02 61810412 00-5750-015-02 61811776 00-5750-015-02 61820645 00-5750-015-02 61824008 00-5750-015-02 61834877 00-5750-015-02 61838758 00-5750-015-02 61847670 00-5750-015-02 61862132 00-5750-015-02 61872331 00-5750-015-02 61876301 00-5750-015-02 61879242 00-5750-015-02 61885147 00-5750-015-02 61886280 00-5750-015-02 61890706 00-5750-015-02 61890043 00-5750-015-02 61904206 00-5750-015-02 61910227 00-5750-015-02 61910229 00-5750-015-02 61910889 00-5750-015-02 61918992 00-5750-015-02 61923590 00-5750-015-02 61936794 00-5750-015-02 61950709 00-5750-015-02 61950710 00-5750-015-02 61960710 00-5750-015-02 61964117 00-5750-015-02 61970682 00-5750-015-02 61973267 00-5750-015-02 61986430 00-5750-015-02 61986739 00-5750-015-02 61996356 00-5750-015-02 61996357 00-5750-015-02 62011576 00-5750-015-02 62011577 00-5750-015-02 62011578 00-5750-015-02 62011579 00-5750-015-02 62022109 00-5750-015-02 62020823 00-5750-015-02 62028437 00-5750-015-02 62033069 00-5750-015-02 62036622 00-5750-015-02 62043322 00-5750-015-02 62050766 00-5750-015-02 62060528 00-5750-015-02 62071255 00-5750-015-02 62075660 00-5750-015-02 62079865 00-5750-015-02 62087941 00-5750-015-02 62092277 00-5750-015-02 62094385 00-5750-015-02 62106698 00-5750-015-02 62107126 00-5750-015-02 62117325 00-5750-015-02 62121774 00-5750-015-02 62132865 00-5750-015-02 62132878 00-5750-015-02 62141732 00-5750-015-02 62141927 00-5750-015-02 62147818 00-5750-015-02 62152394 00-5750-015-02 62156825 00-5750-015-02 62166658 00-5750-015-02 62166748 00-5750-015-02 62171101 00-5750-015-02 62171102 00-5750-015-02 62171757 00-5750-015-02 62171762 00-5750-015-02 62171764 00-5750-015-02 62173170 00-5750-015-06 61797739 00-5750-015-06 61830366 00-5750-015-06 62003582 00-5750-015-06 62091562 00-5750-015-06 62122538 00-5750-015-06 62141936 00-5750-016-01 61794718 00-5750-016-01 61796369 00-5750-016-01 61804735 00-5750-016-01 61823887 00-5750-016-01 61834861 00-5750-016-01 61843134 00-5750-016-01 61879330 00-5750-016-01 61886333 00-5750-016-01 61890709 00-5750-016-01 61905190 00-5750-016-01 61905191 00-5750-016-01 61914487 00-5750-016-01 61929422 00-5750-016-01 61936004 00-5750-016-01 61946957 00-5750-016-01 61955579 00-5750-016-01 61962742 00-5750-016-01 61962744 00-5750-016-01 61976418 00-5750-016-01 61982466 00-5750-016-01 61996959 00-5750-016-01 62005925 00-5750-016-01 62007016 00-5750-016-01 62013511 00-5750-016-01 62022325 00-5750-016-01 62022324 00-5750-016-01 62034567 00-5750-016-01 62044626 00-5750-016-01 62063739 00-5750-016-01 62072219 00-5750-016-01 62080345 00-5750-016-01 62092539 00-5750-016-01 62093019 00-5750-016-01 62112670 00-5750-016-01 62119497 00-5750-016-01 62125812 00-5750-016-01 62137994 00-5750-016-01 62144301 00-5750-016-01 62152969 00-5750-016-01 62155068 00-5750-016-01 62171793 00-5750-016-05 61836353 00-5750-016-05 61970691 00-5750-016-05 11006472 00-5750-016-05 62093021 00-5750-016-05 62100379 00-5750-016-05 62126817 00-5750-016-02 61796371 00-5750-016-02 61798627 00-5750-016-02 61809722 00-5750-016-02 61819934 00-5750-016-02 61823891 00-5750-016-02 61823892 00-5750-016-02 61829840 00-5750-016-02 61844041 00-5750-016-02 61846258 00-5750-016-02 61867611 00-5750-016-02 61876284 00-5750-016-02 11400202 00-5750-016-02 61888046 00-5750-016-02 61893643 00-5750-016-02 61900478 00-5750-016-02 61905269 00-5750-016-02 61905271 00-5750-016-02 61914490 00-5750-016-02 61922259 00-5750-016-02 61936008 00-5750-016-02 61936677 00-5750-016-02 61946960 00-5750-016-02 61959246 00-5750-016-02 61959248 00-5750-016-02 11400318 00-5750-016-02 61968824 00-5750-016-02 61968857 00-5750-016-02 61976430 00-5750-016-02 61988466 00-5750-016-02 61989668 00-5750-016-02 61997351 00-5750-016-02 62005963 00-5750-016-02 62014079 00-5750-016-02 62014080 00-5750-016-02 62022326 00-5750-016-02 62022327 00-5750-016-02 62038034 00-5750-016-02 62046244 00-5750-016-02 62064361 00-5750-016-02 62073119 00-5750-016-02 62080827 00-5750-016-02 62088862 00-5750-016-02 62094391 00-5750-016-02 62106555 00-5750-016-02 62112673 00-5750-016-02 62130983 00-5750-016-02 62138093 00-5750-016-02 62146939 00-5750-016-02 62154050 00-5750-016-02 62163077 00-5750-016-02 62171794 00-5750-016-06 61843136 00-5750-016-06 61982989 00-5750-016-06 62007752 00-5750-016-06 62094390 00-5750-016-06 62138249 00-5750-017-01 61830532 00-5750-017-01 61870826 00-5750-017-01 61889195 00-5750-017-01 11400212 00-5750-017-01 11400228 00-5750-017-01 61943192 00-5750-017-01 61970695 00-5750-017-01 61977555 00-5750-017-01 62003098 00-5750-017-01 62036516 00-5750-017-01 62075677 00-5750-017-01 62134276 00-5750-017-01 62164340 00-5750-017-01 62172421 00-5750-017-05 62134278 00-5750-017-02 61830533 00-5750-017-02 61870831 00-5750-017-02 61890024 00-5750-017-02 61904207 00-5750-017-02 61906387 00-5750-017-02 61926131 00-5750-017-02 61931674 00-5750-017-02 61958023 00-5750-017-02 61963893 00-5750-017-02 61984229 00-5750-017-02 62003103 00-5750-017-02 62036517 00-5750-017-02 62081907 00-5750-017-02 62091452 00-5750-017-02 62146658 00-5750-017-02 62172422 00-5750-017-06 62134277 00-5750-017-06 62173183

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 47 of 48

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

Z-1060-2018

Recall number: Z-1060-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5414-013-02 61768287 00-5414-013-02 61768287R 00-5414-013-02 77001023 00-5414-013-02 61871391 00-5414-013-02 61876203 00-5414-013-02 61889334 00-5414-013-02 61910523 00-5414-013-02 61940029 00-5414-013-02 61971424 00-5414-013-02 61983528 00-5414-013-02 61994980 00-5414-013-02 62001882 00-5414-013-02 62020365 00-5414-013-02 62032695 00-5414-013-02 11006436 00-5414-013-02 62046201 00-5414-013-02 62054637 00-5414-013-02 62054637R 00-5414-013-02 62074928 00-5414-013-02 62094873 00-5414-013-02 62103499 00-5414-013-02 62117187 00-5414-013-02 62128275 00-5414-017-01 61777741 00-5414-017-01 61801560 00-5414-017-01 77001027 00-5414-017-01 61837057 00-5414-017-01 61867209 00-5414-017-01 61885276 00-5414-017-01 61889362 00-5414-017-01 61872013 00-5414-017-01 61904178 00-5414-017-01 61904178R 00-5414-017-01 61910561 00-5414-017-01 11004925 00-5414-017-01 61928674 00-5414-017-01 61952632 00-5414-017-01 61963823 00-5414-017-01 61971475 00-5414-017-01 61988083 00-5414-017-01 61994991 00-5414-017-01 62005770 00-5414-017-01 77001464 00-5414-017-01 62025843 00-5414-017-01 62041147 00-5414-017-01 62054638 00-5414-017-01 11006490 00-5414-017-01 62062144 00-5414-017-01 62074934 00-5414-017-01 62094875 00-5414-017-01 62117197 00-5414-017-02 61774297 00-5414-017-02 61824684 00-5414-017-02 61871418 00-5414-017-02 61876224 00-5414-017-02 61889363 00-5414-017-02 61899535 00-5414-017-02 61904179 00-5414-017-02 61933394 00-5414-017-02 61950165 00-5414-017-02 61928675 00-5414-017-02 61950166 00-5414-017-02 61952633 00-5414-017-02 61950164 00-5414-017-02 11005236 00-5414-017-02 11005311 00-5414-017-02 61958472 00-5414-017-02 61994989 00-5414-017-02 62001895 00-5414-017-02 62005771 00-5414-017-02 62025844 00-5414-017-02 62054634 00-5414-017-02 62046213 00-5414-017-02 62062145 00-5414-017-02 62074937 00-5414-017-02 11006896 00-5414-017-02 62104630 00-5414-017-02 62110727

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

device · product 48 of 48

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

Z-1061-2018

Recall number: Z-1061-2018
Initiated: November 29, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 13,227 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Code information

00-5412-015-02 61777756 00-5412-015-02 11003149 00-5412-015-02 61782977 00-5412-015-02 61796047 00-5412-015-02 61806563 00-5412-015-02 61806562 00-5412-015-02 61867212 00-5412-015-02 61867213 00-5412-015-02 61872035 00-5412-015-02 61871424 00-5412-015-02 11004422 00-5412-015-02 11004477 00-5412-015-02 61876226 00-5412-015-02 61885240 00-5412-015-02 61889370 00-5412-015-02 61894436 00-5412-015-02 61899511 00-5412-015-02 11001440 00-5412-015-02 61904154 00-5412-015-02 61916029 00-5412-015-02 61921361 00-5412-015-02 61928677 00-5412-015-02 61940207 00-5412-015-02 61952635 00-5412-015-02 61963807 00-5412-015-02 61968948 00-5412-015-02 61988106 00-5412-015-02 11005840 00-5412-015-02 61983536 00-5412-015-02 61975655 00-5412-015-02 61995014 00-5412-015-02 61988107 00-5412-015-02 62001897 00-5412-015-02 62013575 00-5412-015-02 62005775 00-5412-015-02 62013586 00-5412-015-02 62013587 00-5412-015-02 11006300 00-5412-015-02 62020383 00-5412-015-02 62025800 00-5412-015-02 62025801 00-5412-015-02 62041160 00-5412-015-02 62032711 00-5412-015-02 62054603 00-5412-015-02 62056958 00-5412-015-02 62062122 00-5412-015-02 62068182 00-5412-015-02 62080694 00-5412-015-02 62074905 00-5412-015-02 62086883 00-5412-015-02 62104646 00-5412-015-02 62104205 00-5412-015-02 62110690 00-5412-015-02 62117168 00-5412-015-02 62122805 00-5412-015-02 62128264 00-5412-016-01 61777757 00-5412-016-01 61777758 00-5412-016-01 61777751 00-5412-016-01 61789818 00-5412-016-01 61782969 00-5412-016-01 61782978 00-5412-016-01 61789819 00-5412-016-01 61789821 00-5412-016-01 61789820 00-5412-016-01 11003194 00-5412-016-01 61796051 00-5412-016-01 61796048 00-5412-016-01 61796049 00-5412-016-01 61796050 00-5412-016-01 11003207 00-5412-016-01 61806564 00-5412-016-01 61806565 00-5412-016-01 61810244 00-5412-016-01 61810277 00-5412-016-01 61810278 00-5412-016-01 61822640 00-5412-016-01 61824650 00-5412-016-01 61831766 00-5412-016-01 61831767 00-5412-016-01 61831768 00-5412-016-01 61831769 00-5412-016-01 61837030 00-5412-016-01 61855584 00-5412-016-01 61858029 00-5412-016-01 61862203 00-5412-016-01 61862254 00-5412-016-01 11004099 00-5412-016-01 61867302 00-5412-016-01 61871426 00-5412-016-01 61871427 00-5412-016-01 61872036 00-5412-016-01 61876227 00-5412-016-01 61876228 00-5412-016-01 61885241 00-5412-016-01 61872037 00-5412-016-01 11004486 00-5412-016-01 11004488 00-5412-016-01 11004571 00-5412-016-01 11004569 00-5412-016-01 61885242 00-5412-016-01 61894438 00-5412-016-01 61889371 00-5412-016-01 61889372 00-5412-016-01 61889373 00-5412-016-01 61894437 00-5412-016-01 61904155 00-5412-016-01 61910532 00-5412-016-01 61899549 00-5412-016-01 61910533 00-5412-016-01 11004855 00-5412-016-01 61916030 00-5412-016-01 61910534 00-5412-016-01 61904156 00-5412-016-01 11004880 00-5412-016-01 11004921 00-5412-016-01 61921362 00-5412-016-01 61921363 00-5412-016-01 61928678 00-5412-016-01 61928679 00-5412-016-01 61933415 00-5412-016-01 61933416 00-5412-016-01 61936720 00-5412-016-01 11005190 00-5412-016-01 11005070 00-5412-016-01 61940208 00-5412-016-01 11005071 00-5412-016-01 61963809 00-5412-016-01 61950171 00-5412-016-01 61952636 00-5412-016-01 61952637 00-5412-016-01 61975656 00-5412-016-01 61958443 00-5412-016-01 61963808 00-5412-016-01 61975657 00-5412-016-01 61958444 00-5412-016-01 61983537 00-5412-016-01 61986587 00-5412-016-01 61988108 00-5412-016-01 61983538 00-5412-016-01 61968949 00-5412-016-01 11005766 00-5412-016-01 61968951 00-5412-016-01 61975660 00-5412-016-01 61975658 00-5412-016-01 61968950 00-5412-016-01 61975659 00-5412-016-01 61991994 00-5412-016-01 61995015 00-5412-016-01 61983550 00-5412-016-01 11005970 00-5412-016-01 61988109 00-5412-016-01 11005971 00-5412-016-01 61995017 00-5412-016-01 61991990 00-5412-016-01 61995016 00-5412-016-01 62001900 00-5412-016-01 62001901 00-5412-016-01 11006008 00-5412-016-01 62001898 00-5412-016-01 11006100 00-5412-016-01 62005777 00-5412-016-01 62005776 00-5412-016-01 62013577 00-5412-016-01 62013576 00-5412-016-01 62013589 00-5412-016-01 62001899 00-5412-016-01 11006234 00-5412-016-01 62013588 00-5412-016-01 62020384 00-5412-016-01 62020386 00-5412-016-01 62020385 00-5412-016-01 62020387 00-5412-016-01 62032712 00-5412-016-01 62032713 00-5412-016-01 11006309 00-5412-016-01 62041161 00-5412-016-01 62041162 00-5412-016-01 62041164 00-5412-016-01 62041163 00-5412-016-01 62046174 00-5412-016-01 62046173 00-5412-016-01 62054604 00-5412-016-01 62054605 00-5412-016-01 62056959 00-5412-016-01 62056961 00-5412-016-01 11006457 00-5412-016-01 62056960 00-5412-016-01 62062123 00-5412-016-01 62062124 00-5412-016-01 62068183 00-5412-016-01 62062125 00-5412-016-01 62074907 00-5412-016-01 62080688 00-5412-016-01 62074906 00-5412-016-01 62074908 00-5412-016-01 62080686 00-5412-016-01 62086884 00-5412-016-01 62080687 00-5412-016-01 62080689 00-5412-016-01 62086885 00-5412-016-01 62092463 00-5412-016-01 62092462 00-5412-016-01 62094870 00-5412-016-01 62103504 00-5412-016-01 11006982 00-5412-016-01 62104181 00-5412-016-01 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00-5412-017-01 61837034 00-5412-017-01 61837035 00-5412-017-01 61871431 00-5412-017-01 61871433 00-5412-017-01 61872040 00-5412-017-01 61867303 00-5412-017-01 61867303R 00-5412-017-01 61885245 00-5412-017-01 61885246 00-5412-017-01 61885247 00-5412-017-01 61876231 00-5412-017-01 11004611 00-5412-017-01 61889376 00-5412-017-01 11004423 00-5412-017-01 61894442 00-5412-017-01 61899513 00-5412-017-01 61894443 00-5412-017-01 61899551 00-5412-017-01 61904159 00-5412-017-01 11004762 00-5412-017-01 61916033 00-5412-017-01 61910535 00-5412-017-01 61910567 00-5412-017-01 61916034 00-5412-017-01 11004927 00-5412-017-01 61916035 00-5412-017-01 11004963 00-5412-017-01 11004964 00-5412-017-01 61921366 00-5412-017-01 61921367 00-5412-017-01 11005044 00-5412-017-01 61940212 00-5412-017-01 61928682 00-5412-017-01 11005301 00-5412-017-01 61936723 00-5412-017-01 61940213 00-5412-017-01 61936722 00-5412-017-01 61950175 00-5412-017-01 61952640 00-5412-017-01 61958448 00-5412-017-01 61975664 00-5412-017-01 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00-5412-017-01 62056965 00-5412-017-01 62056965R 00-5412-017-01 62074911 00-5412-017-01 62062131 00-5412-017-01 62062132 00-5412-017-01 62062130 00-5412-017-01 62068188 00-5412-017-01 62068189 00-5412-017-01 62074912 00-5412-017-01 11006765 00-5412-017-01 11006815 00-5412-017-01 62086890 00-5412-017-01 62092467 00-5412-017-01 62080692 00-5412-017-01 62092469 00-5412-017-01 62104647 00-5412-017-01 11007002 00-5412-017-01 62104206 00-5412-017-01 62046178 00-5412-017-01 62092468 00-5412-017-01 62110695 00-5412-017-01 62110696 00-5412-017-01 62080695 00-5412-017-01 62117175 00-5412-017-01 62122808 00-5412-017-01 62128270 00-5412-017-02 61777752 00-5412-017-02 61777763 00-5412-017-02 11003153 00-5412-017-02 61782981 00-5412-017-02 61782982 00-5412-017-02 61789829 00-5412-017-02 61796057 00-5412-017-02 61796057R 00-5412-017-02 61789841 00-5412-017-02 61796056 00-5412-017-02 61801509 00-5412-017-02 61796058 00-5412-017-02 61801510 00-5412-017-02 61801511 00-5412-017-02 61810247 00-5412-017-02 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00-5412-017-02 61958450 00-5412-017-02 61963814 00-5412-017-02 61963815 00-5412-017-02 61952642 00-5412-017-02 61950173 00-5412-017-02 61940214 00-5412-017-02 61950174 00-5412-017-02 61958449 00-5412-017-02 61968956 00-5412-017-02 61952643 00-5412-017-02 61975670 00-5412-017-02 61975669 00-5412-017-02 61983546 00-5412-017-02 61991993 00-5412-017-02 61991997 00-5412-017-02 61983545 00-5412-017-02 61975668 00-5412-017-02 61968957 00-5412-017-02 61968958 00-5412-017-02 11005889 00-5412-017-02 61983553 00-5412-017-02 61983547 00-5412-017-02 61986591 00-5412-017-02 61988113 00-5412-017-02 61975671 00-5412-017-02 61995024 00-5412-017-02 62001907 00-5412-017-02 61995025 00-5412-017-02 11006045 00-5412-017-02 62001909 00-5412-017-02 62005782 00-5412-017-02 62005783 00-5412-017-02 62005784 00-5412-017-02 62013583 00-5412-017-02 62013584 00-5412-017-02 62013593 00-5412-017-02 62001908 00-5412-017-02 62013582 00-5412-017-02 62020394 00-5412-017-02 62020395 00-5412-017-02 62032718 00-5412-017-02 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00-5412-018-01 61867216 00-5412-018-01 61872043 00-5412-018-01 61889378 00-5412-018-01 61910536 00-5412-018-01 61958451 00-5412-018-01 61958488 00-5412-018-01 61971299 00-5412-018-01 61975673 00-5412-018-01 61975672 00-5412-018-01 61986592 00-5412-018-01 11005767 00-5412-018-01 61988114 00-5412-018-01 61995026 00-5412-018-01 62005785 00-5412-018-01 77001458 00-5412-018-01 77001460 00-5412-018-01 77001459 00-5412-018-01 77001459R 00-5412-018-01 62001910 00-5412-018-01 62001910R 00-5412-018-01 77001462 00-5412-018-01 77001461 00-5412-018-01 77001483 00-5412-018-02 61777754 00-5412-018-02 61782984 00-5412-018-02 11003184 00-5412-018-02 11003184R 00-5412-018-02 11003166 00-5412-018-02 61801512 00-5412-018-02 61806574 00-5412-018-02 61810285 00-5412-018-02 61850060 00-5412-018-02 11004266 00-5412-018-02 61867304 00-5412-018-02 61872044 00-5412-018-02 11004519 00-5412-018-02 61889379 00-5412-018-02 61910537 00-5412-018-02 61928684 00-5412-018-02 61971308 00-5412-018-02 61991998 00-5412-018-02 61983548 00-5412-018-02 11005930 00-5412-018-02 61995027 00-5412-018-02 61988115 00-5412-018-02 62001911 00-5412-018-02 62001911R 00-5412-018-02 62005786 00-5412-018-02 77001454 00-5412-018-02 77001452 00-5412-018-02 77001457 00-5412-018-02 77001456 00-5412-018-02 77001455 00-5412-018-02 77001453 00-5412-018-02 62117177

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

Event summary

Source snapshots represented here

Every recalled product in this event

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