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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Zimmer Biomet, Inc.: Potential failure of sterile packaging seal.

Agency Publication Date: April 20, 2018
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Affected Products

Product: M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

Lot Numbers: 63733049 63738623 63748399 63753770 63758430 63849380 77006555 77006556 77006557

Lot Numbers:
Numbers
Product: Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00

Lot Numbers: 63738593 63738594 63738595 63738596 63748395 63748396 63748397 63748398 63753767 63753768 63758425 63758428 63771163 77006530 77006531 77006532 77006533 77006534 77006535 77006536 77006537 77006538 77006539 77006540 77006541 77006542 77006543 77006544 77006545

Lot Numbers:
Numbers
Product: Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00

Lot Numbers: 63631729 63638177 63645647 63645648 63662542 63681727 63690177 63690178 63733040 63733041 63733042 63748389 63753764 63758424 63771141 63780123 63787478 63826236 77006549 77006550 77006551 77006553 77006558 63836288

Lot Numbers:
Numbers
Product: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01

Lot Numbers: 63733044 63748390 63748391 77006546 77006547 77006548

Lot Numbers:
Numbers
Product: Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00

Lot Numbers: 63609177 63631715 63638172 63638173 63638175 63638176 63645643 63645644 63655990 63655991 63655992 63655993 63655994 63662538 63662539 63662540 63662541 63668694 63668695 63668696 63668697 63675668 63675669 63675670 63675704 63675705 63681724 63681726 63681728 63690176 63690179 63690180 63705228 63705229 63709163 63709164 63709165 63709166 63715680 63715681 63715682 63715683 63721368 63721369 63721370 63721371 63731169 63748392 63753760 63753761 63753762 63753763 63758420 63758421 63758422 63758423 63771066 63771067 63780119 63780120 63780121 63780122 63781875 63781876 63781877 63781878 63787475 63787476 63787477 63796531 63796532 63796533 63796534 63796535 63803579 63803581 63803583 63803591 63803592 63812281 63812283 63812284 63812285 63817702 63817704 63817705 63844026 63812282 63817701 63826234 63826235 63836285 63844028

Lot Numbers:
Numbers
Product: ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00

Lot Numbers: 63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242

Lot Numbers:
Numbers
Product: Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00

Lot Numbers: 63655999 63715685 63731170 63733045 63812299

Lot Numbers:
Numbers
Product: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01

Lot Numbers: 63631719 63668698 63705230 63705231 63731168 63771071 63787479

Lot Numbers:
Numbers
Product: Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01

Lot Numbers: 63619923 63625354 63625355 63625356 63631736 63631737 63638178 63638179 63638180 63638181 63639395 63639396 63639397 63639398 63639399 63639401 63645656 63645657 63645658 63645659 63648799 63648801 63648802 63648803 63650117 63650118 63651633 63651634 63651635 63656843 63662543 63662544 63662545 63662546 63662547 63668702 63668703 63668721 63675676 63675677 63681732 63681733 63681734 63681735 63690182 63690183 63690184 63690185 63696959 63696960 63696961 63705243 63705244 63705245 63705246 63709167 63709168 63709169 63709170 63715687 63715688 63721372 63721373 63721374 63721375 63731172 63731173 63731174 63731175 63733047 63733048 63764548 63771161 63771162 63780124 63780125 63781880 63803593 63812301 63796536 63796537

Lot Numbers:
Numbers
Product: M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00

Lot Numbers: 63733046 63758426 77006554

Lot Numbers:
Numbers
Product: ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00

Lot Numbers: 63715690 63780127 63787482

Lot Numbers:
Numbers
Product: ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00

Lot Numbers: 63645655 63650115 63650116 63655995 63655996 63655997 63655998

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79681
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 12 products (19483 total products; 19483 total products; 19483 total products; 19483 total products; 19483 total products; 19483 total products; 19483 total products; 19,483 total products; 19,483 total products; 19,483 total products; 19,483 total products; 19,483 total products)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.