FDA event 77417 · Recall Observatory

device · product 1 of 60

Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile

Z-3144-2017

Recall number: Z-3144-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 2825 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 2 of 60

Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile

Z-3145-2017

Recall number: Z-3145-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63561678, 63444450 & 63475217.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 3 of 60

Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.

Z-3146-2017

Recall number: Z-3146-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63562128

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 4 of 60

M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgical instrument.

Z-3147-2017

Recall number: Z-3147-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63562128

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 5 of 60

ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.

Z-3148-2017

Recall number: Z-3148-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 751 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 6 of 60

Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgical instrument.

Z-3149-2017

Recall number: Z-3149-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 171 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 7 of 60

ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.

Z-3150-2017

Recall number: Z-3150-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63584061 & 63634136

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 8 of 60

Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument.

Z-3151-2017

Recall number: Z-3151-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1055 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63584061 & 63634136

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 9 of 60

Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.

Z-3152-2017

Recall number: Z-3152-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 155 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63550419, 63556696, 63566195, 63641526, 63326478, 63358155, 63364056, 63462112, 63474138, 63484940, 63492343, 63524330 & 6350361

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 10 of 60

Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.

Z-3153-2017

Recall number: Z-3153-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63550419, 63556696, 63566195, 63641526, 63326478, 63358155, 63364056, 63462112, 63474138, 63484940, 63492343, 63524330 & 6350361

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 11 of 60

NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.

Z-3154-2017

Recall number: Z-3154-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 300 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63385956, 63405774 & 63445667

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 12 of 60

M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.

Z-3155-2017

Recall number: Z-3155-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 224 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63616770, 63616771, 63616772, 63413732, 63413734, 63413737, 63443859, 63443861, 63443836, 63469287, 63469288, 63469289, 63474646, 63474647, 63474648, 63511483, 63529994, 63529995, 63529996 & 63530003

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 13 of 60

ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orthopedic surgical instrument.

Z-3156-2017

Recall number: Z-3156-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63517946

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 14 of 60

NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.

Z-3157-2017

Recall number: Z-3157-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 185 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63570344

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 15 of 60

M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.

Z-3158-2017

Recall number: Z-3158-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 182 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63574676, 63574677, 63574678, 63424385, 63451742, 63493677 & 63493680

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 16 of 60

M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrument.

Z-3159-2017

Recall number: Z-3159-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63505310

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 17 of 60

M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.

Z-3160-2017

Recall number: Z-3160-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63329859

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 18 of 60

ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.

Z-3161-2017

Recall number: Z-3161-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 439 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63562129, 63578148, 63377521, 63398755, 63415317, 63431736, 63438195, 63438272, 63444661, 63462322, 63474385, 63485128, 63497202, 63505360, 63510813, 63524432 & 63530407.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 19 of 60

ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile. orthopedic surgical instrument.

Z-3162-2017

Recall number: Z-3162-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1999 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63610789, 63610790, 63333727, 63340530, 63364066, 63364067, 63384623, 63398757, 63431747, 63444664, 63444666, 63444667, 63444668, 63462334, 63462340, 63474387, 63485135, 63485138, 63485141, 63497203, 63497204, 63507361 & 63540409

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 20 of 60

ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrument.

Z-3163-2017

Recall number: Z-3163-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1558 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545279, 63610791, 63641572, 63333729, 63333730, 63333732, 63340531, 63364064, 63364065, 63372902, 63384626, 63384629, 63444670, 63444671, 63457776, 63457945, 63462343, 63462344, 63474390, 63497205, 63497206, 63505362, 63510815, 63535517, 63535518 & 63722007.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 21 of 60

ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.

Z-3164-2017

Recall number: Z-3164-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 4,423 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545283, 63578152, 63578153, 63584052, 63358182, 63358184, 63364075, 63384616, 63384617, 63384618, 63398734, 63398735, 63415287, 63415288, 63426487, 63426488, 63431725, 63431730, 63438313, 63438315, 63438316, 63438318, 63444673, 63444674, 63444676, 63444677, 63444678, 63444680, 63444681, 63469895, 93468987, 63469898, 63469901, 63499636, 63499638, 63499640, 63499641, 63510882, 63510883, 63510884, 63510885, 63524433, 63535519 & 63535520.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 22 of 60

ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical instrument.

Z-3165-2017

Recall number: Z-3165-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 3,640 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63535521, 63535522, 63535523, 63535524, 63545285, 63562130, 63578154, 63578156, 63358058, 63358059, 63358060, 63358061, 63364050, 63377480, 63377481, 63377482, 63384605, 63384606, 63384607, 63398721, 63398722, 63398723, 63398724, 63398736, 63398738, 63415279, 63415280, 63415282, 63415283, 63415284, 63415286, 63426490, 63426491, 63431727, 63431728, 63431729, 63438323, 63438326, 63444503, 63444514, 63444682, 63444683, 63444684, 63444685, 63444686, 63457777, 63457946, 63457947, 63457948, 63469905, 63469907, 63510887, 63510888, 63517978, 63517997, 63518010 & 63524434.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 23 of 60

ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument.

Z-3166-2017

Recall number: Z-3166-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 3,232 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545287, 63315176, 63315178, 63315180, 63319001, 63333734, 63333736, 63333737, 63333795, 63333799, 63340564, 63340568, 63347076, 63350788, 63358204, 63384635, 63415299, 63415303, 63426466, 63426492, 63457631, 63457779, 63457780, 63457781, 63457949, 63469913, 63469915, 63469917, 63469919, 63474421, 63478996, 63518027, 63518029 & 63518031.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 24 of 60

ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.

Z-3167-2017

Recall number: Z-3167-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 2,240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545289, 63545291, 63578158, 63326460, 63333735, 63333738, 63333802, 63340556, 63340559, 63340563, 63347073, 63347075, 63350786, 63350787, 63358205, 63358206, 63384637, 63384658, 63384660, 63398760, 63415294, 63415296, 63426493, 63444520, 63457643, 63457784, 63457785, 63457787, 63457791, 63457950, 63469922, 63469924, 63469933, 63474430, 63478998 & 63518034.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 25 of 60

ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile. orthopedic surgical instrument.

Z-3168-2017

Recall number: Z-3168-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1,250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63556698, 63630276, 63630277, 63358163, 63364072, 63372863, 63415324, 63415327, 63426481, 63457812, 63457820, 63457825, 63469937, 63469939, 63474431, 63474432, 63474433, 63524435 & 63524436.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 26 of 60

ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instrument.

Z-3169-2017

Recall number: Z-3169-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1,286 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63556699, 63556701, 63593922, 63616886, 63630279, 63641603, 63358167, 63372864, 63372865, 63377514, 63377516, 63415331, 63426482, 63431757, 63457850, 63457853, 63457856, 63469884, 63474434, 63479002, 63479004, 63479006 & 63524437.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 27 of 60

ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. orthopedic surgical instrument.

Z-3170-2017

Recall number: Z-3170-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1,255 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63556702, 63593924, 63593925, 63616888, 63340538, 63340539, 63358202, 63358203, 63372868, 63398777, 63478700, 63479007, 63479008, 63479009, 63517947 & 63524439.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 28 of 60

ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.

Z-3171-2017

Recall number: Z-3171-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 2,038 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63556703, 63566220, 63593926, 63593928, 63593930, 63630281, 63340536, 63340537, 63347015, 63347018, 63347022, 63347034, 63358186, 63358201, 63372867, 63398739, 63398761, 63398762, 63426475, 63426476, 63426478, 63431754, 63431755, 63457862, 63457863, 63457865, 63457889, 63474135, 63479010, 63479011, 63479013, 63524442, 63524443 & 63524445.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 29 of 60

ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.

Z-3172-2017

Recall number: Z-3172-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 356 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63556745, 63630284, 63641610, 63358212, 63364073, 63457891, 63479015, 63479016 & 63524446.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 30 of 60

ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrument.

Z-3173-2017

Recall number: Z-3173-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 389 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63556890, 63630297, 63358210, 63431706, 63444526, 63457649, 63457893, 63479021 & 63524448.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 31 of 60

Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.

Z-3174-2017

Recall number: Z-3174-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 173 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63557051, 63451624, 63451625, 63451627, 63457895, 63517948 & 63524449.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 32 of 60

Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.

Z-3175-2017

Recall number: Z-3175-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63457688, 63474136 & 63524451

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 33 of 60

ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile. orthopedic surgical instrument.

Z-3176-2017

Recall number: Z-3176-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 381 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63641616, 63457898, 63478702, 63479022, 63479023 & 63524453

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 34 of 60

ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrument.

Z-3177-2017

Recall number: Z-3177-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 217 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63593911, 63457691, 63457909, 63479024 & 63524454.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 35 of 60

Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.

Z-3178-2017

Recall number: Z-3178-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63578494, 63641443 & 63524035.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 36 of 60

Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. orthopedic surgical instrument.

Z-3179-2017

Recall number: Z-3179-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 173 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545430, 63578497, 63586028, 63606286, 63610624, 63635345, 63458048, 63469766, 63475222 & 63530224.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 37 of 60

Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical instrument.

Z-3180-2017

Recall number: Z-3180-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1,091 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63599481, 63461425, 63469758, 63469758, 63475225 & 63481881.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 38 of 60

Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical instrument.

Z-3181-2017

Recall number: Z-3181-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1,129 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63557936, 63566282, 63574978 & 63623144.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 39 of 60

ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile. orthopedic surgical instrument.

Z-3182-2017

Recall number: Z-3182-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 418 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63557936, 63566282, 63574978 & 63623144.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 40 of 60

ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile. orthopedic surgical instrument.

Z-3183-2017

Recall number: Z-3183-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 37 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545295, 63634139, 63634141 & 63530410.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 41 of 60

ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile. orthopedic surgical instrument.

Z-3184-2017

Recall number: Z-3184-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63289918, 63296044, 63451593, 63457958, 63462351, 63469945, 63479047 & 63518080.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 42 of 60

ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic surgical instrument.

Z-3185-2017

Recall number: Z-3185-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63289918, 63296044, 63451593, 63457958, 63462351, 63469945, 63479047 & 63518080.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 43 of 60

ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgical instrument.

Z-3186-2017

Recall number: Z-3186-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63306444, 63315170, 63350728, 63364047, 63377460, 63474111, 63474113, 63499659 & 63499667.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 44 of 60

ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgical instrument.

Z-3187-2017

Recall number: Z-3187-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63510893

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 45 of 60

ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.

Z-3188-2017

Recall number: Z-3188-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63518082

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 46 of 60

Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile. orthopedic surgical instrument.

Z-3189-2017

Recall number: Z-3189-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63606634

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 47 of 60

Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument.

Z-3190-2017

Recall number: Z-3190-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Number: 63602805

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 48 of 60

Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument.

Z-3191-2017

Recall number: Z-3191-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 228 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63550421, 63570257, 63634090, 63306459, 63377487 & 63492354

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 49 of 60

Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile. orthopedic surgical instrument.

Z-3192-2017

Recall number: Z-3192-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 705 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63570260, 63574325, 63584027, 63451638, 63451640, 63457758, 63457921, 63478937, 63478942, 63478945, 63484951, 63492357, 63496853 & 63510771.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 50 of 60

Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.

Z-3193-2017

Recall number: Z-3193-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 2,585 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545255, 63562124, 63566199, 63566218, 63584030, 63398778, 63426469, 63431693, 63431763, 63444579, 63444581, 63444582, 63444584, 63444587, 63451645, 63451647, 63451648, 63451649, 63451651, 63451655, 63462151, 63462166, 63462170, 63462174, 63474142, 63478948, 63484963, 63484966, 63484973, 63492362, 63492363, 63505347, 63505348, 63510772, 63510773 & 63524431.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 51 of 60

Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile. orthopedic surgical instrument.

Z-3194-2017

Recall number: Z-3194-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 701 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545256, 63550424, 63457944, 63462196, 63462201, 63469886, 63474144, 63484983, 63492364, 63496869, 63505349, 63510774 & 63530385.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 52 of 60

Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical instrument.

Z-3195-2017

Recall number: Z-3195-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1,550 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63545257, 63545258, 63451724, 63451725, 63451728, 63451730, 63451744, 63451747, 63451751, 63451753, 63451754, 63462227, 63478968, 63478972, 63478974, 63485102, 63530392 & 63530394.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 53 of 60

Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.

Z-3196-2017

Recall number: Z-3196-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 3,154 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63562125, 63574359, 63584041, 63596754, 63634173, 63364063, 63426473, 63431723, 63444632, 63462281, 63474170, 63496895, 63496896 & 63530398.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 54 of 60

Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument.

Z-3197-2017

Recall number: Z-3197-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 236 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63574361, 63596765, 63596770, 63530401 & 63535496.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 55 of 60

Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile. orthopedic surgical instrument.

Z-3198-2017

Recall number: Z-3198-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 595 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63593915, 63641547, 63415314, 63462286 & 63510812.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 56 of 60

Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.

Z-3199-2017

Recall number: Z-3199-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63570251, 63570254, 63593917 & 63462292.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 57 of 60

Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orthopedic surgical instrument.

Z-3200-2017

Recall number: Z-3200-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 453 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63301761, 63384613, 63431786, 63469892 & 63530404.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 58 of 60

Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile. orthopedic surgical instrument.

Z-3201-2017

Recall number: Z-3201-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 2,037 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63541085, 63565537, 63586553, 63586554, 63635381, 63635382, 63660536, 63329874, 63329875, 63343934, 63343935, 63361695, 63370747, 63388956, 63399691, 63399692, 63413799, 63413801, 63413803, 63413804 & 63499022.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 59 of 60

Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.

Z-3202-2017

Recall number: Z-3202-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63616857, 63469869, 63492339 & 63530402.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

device · product 60 of 60

Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument.

Z-3203-2017

Recall number: Z-3203-2017
Initiated: May 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information

Lot Numbers: 63570253, 63574369, 63584044, 63622717 & 63634109.

Distribution pattern

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

Event summary

Source snapshots represented here

Every recalled product in this event

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