Recall Z-2321-2016— Zimmer Gmbh
Class II · Terminated
Class II FDA medical device recall by Zimmer Gmbh, initiated 2016-06-27, terminated 2017-05-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Zimmer Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-27
- Terminated
- 2017-05-30
- Firm location
- Winterthur, Switzerland
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.