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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80188

15 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 30, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

15 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 15

Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40

Z-2361-2018
Recall number
Z-2361-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
280

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

61967700 62386066 62386068 62410987 62416627 62445412 62450669 62458974 62472166 62484291 62503192 62515309 62594187 62601210 62615697 62622678 62636747 62665742 62681670 62740032 62797379 62797380 62882393 62917816 62114291R 77003795R

Distribution pattern

Products were distributed solely to Japan.

device · product 2 of 15

Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10

Z-2362-2018
Recall number
Z-2362-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
294

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

62107667 62410983 62410984 62445410 62449677 62450635 62469393 62478848 62478852 62478855 62503181 62547038 62554172 62559999 62560152 62577929 62630007 62636746 62652981 62659334 62667678 62753395 62770876 62777941 62791158 62806022 62897465

Distribution pattern

Products were distributed solely to Japan.

device · product 3 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00

Z-2363-2018
Recall number
Z-2363-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
227

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

61930610 61967651 62010520 62053333 62430587 62460391 62503140 62794209 62876154 62927048 63034172 63034173 63034174 63038714 63076525 63081182 63128514 63128518 63161307

Distribution pattern

Products were distributed solely to Japan.

device · product 4 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00

Z-2364-2018
Recall number
Z-2364-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
96

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

62044925 62571340 62831345 62869740 62953032 63068885 63081184 63089967

Distribution pattern

Products were distributed solely to Japan.

device · product 5 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00

Z-2365-2018
Recall number
Z-2365-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
24

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

62361460 62528141

Distribution pattern

Products were distributed solely to Japan.

device · product 6 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11; 00-7713-011-00

Z-2366-2018
Recall number
Z-2366-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
132

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

62432961 62848695 62914651 62927105 62927112 63068929 63081264 63090024 63090028 63116798 63161432

Distribution pattern

Products were distributed solely to Japan.

device · product 7 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00

Z-2367-2018
Recall number
Z-2367-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
84

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

61741690 62808128 62831371 63068944 63090038 63094522 63128589

Distribution pattern

Products were distributed solely to Japan.

device · product 8 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00

Z-2368-2018
Recall number
Z-2368-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
510

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

61349197 61690629 61721526 61781828 62010553 62118873 62130040 62201735 62258067 62275219 62356222 62361475 62484285 62496087 62546976 62559966 62578405 62616562 62634733 62652960 62700955 62733912 62798024 62808130 62808133 62869767 62869769 62953079 62993667 62993703 63034232 63038804 63044938 63068954 63068955 63068957 63076577 63081279 63094534 63094538 63102051 63128592 63128593 62521418R 62939011R 63128592R 77002646R

Distribution pattern

Products were distributed solely to Japan.

device · product 9 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00

Z-2369-2018
Recall number
Z-2369-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
1024

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

61288759 61542760 61710043 61729725 61735130 61768446 61805951 61843648 61874222 61950885 61957017 61967640 61967642 61985977 62010557 62014550 62059104 62124960 62134980 62153554 62163677 62191383 62225911 62270944 62273474 62275220 62275874 62316364 62329143 62356225 62418056 62420829 62420831 62420832 62432973 62472159 62503173 62521423 62521424 62521425 62521426 62540539 62571382 62578409 62652963 62659314 62659315 62667476 62700958 62721036 62739979 62761717 62776407 62787314 62787315 62794382 62815408 62836783 62836785 62885067 62939020 62939021 62939023 63044942 63051893 63063344 63063345 63063346 63063348 63068961 63068965 63068967 63068969 63076579 63076580 63081284 63081286 63090043 63090044 63094542 63102029 63102030 63108843 63174078 63174079 63174081 77004214 61429027R 62066989R 62335432R 62836786R

Distribution pattern

Products were distributed solely to Japan.

device · product 10 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00

Z-2370-2018
Recall number
Z-2370-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
665

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

60936172 61002401 61150834 61326535 61332941 61359861 61375746 61403159 61409715 61459935 61479150 61559581 61729731 61741696 61757673 62014555 62014556 62014557 62059105 62071437 62118877 62130043 62163680 62207789 62282107 62323345 62356227 62420836 62432974 62503175 62521427 62560139 62578410 62586781 62616563 62647184 62659327 62694084 62707654 62721037 62782080 62803651 62927127 62939025 62953083 63063349 63063351 63063352 63068972 63090045 63090046 63090047 63116808 63116809 63116810 77004216 61590535R 62071437R

Distribution pattern

Products were distributed solely to Japan.

device · product 11 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00

Z-2371-2018
Recall number
Z-2371-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
182

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

11016141 60936173 60964158 61086272 62059106 62361479 62521429 62659329 62694085 62745241 62782081 63063354 63063356 63063357 63063358 77004218 77004219 61991590R

Distribution pattern

Products were distributed solely to Japan.

device · product 12 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00

Z-2372-2018
Recall number
Z-2372-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
138

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

00114166 61068340 61081252 61269285 61294384 61308863 61729730 61774484 61985982 62225912 62356231 62478335 77004221

Distribution pattern

Products were distributed solely to Japan.

device · product 13 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5; 00-7713-022-00

Z-2373-2018
Recall number
Z-2373-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
101

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

00111778 60940196 61025425 61063904 61097911 61120383 61134445 61619526 62420837 62798037

Distribution pattern

Products were distributed solely to Japan.

device · product 14 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00

Z-2374-2018
Recall number
Z-2374-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
58

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

62420821 62745221 62848683 63089985 63161324 62647157R

Distribution pattern

Products were distributed solely to Japan.

device · product 15 of 15

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00

Z-2375-2018
Recall number
Z-2375-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
116

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

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

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Code information

62350575 62647167 62787292 63044896 63044897 63068905 63076554 63120523 63161387 63174034

Distribution pattern

Products were distributed solely to Japan.