Zimmer Gmbh: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.

Agency Publication Date: August 2, 2016

Affected Products

Product: TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12

Lot Numbers:

Numbers

Product: TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015629; Lot Numbers: 7975/188D10, 10409/188A12, 10408/188A12

Lot Numbers:

Numbers

Product: V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015635; Lot Numbers:9721/188D11

Lot Numbers:

Numbers

Product: V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015640; Lot Numbers:27374, 104547/188A9

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74548

Status: Resolved

Manufacturer: Zimmer Gmbh

Manufactured In: Switzerland

Units Affected: 4 products (169)

Were You Affected by This Recall?

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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

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Affected Products

Product: TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12

Lot Numbers:

Numbers

Product: TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015629; Lot Numbers: 7975/188D10, 10409/188A12, 10408/188A12

Lot Numbers:

Numbers

Product: V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015635; Lot Numbers:9721/188D11

Lot Numbers:

Numbers

Product: V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Part No.: 502015640; Lot Numbers:27374, 104547/188A9

Lot Numbers:

Numbers