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High RiskFDAfda-Z-2323-2016OTHER

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 syst...

Units Affected
169
Recall Date
June 27, 2016
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2323-2016.

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.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2323-2016.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Zimmer Gmbh or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2323-2016.

Zimmer Gmbh

FDA

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Zimmer Gmbh Recall FAQ

Zimmer Gmbh is the subject of a medical implants safety report: 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 syst.... The notice was published on June 27, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 169 units are potentially affected.