FDA Device recall Z-2321-2016
TWIST DR 25X95MM Cann 12MM Thd 30MM AO
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of TWIST DR 25X95MM Cann 12MM Thd 30MM AO by Zimmer, citing 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 Kirsch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2321-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-27 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer |
| Distribution | CO, IL |
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.
Identifiers
| code_info | Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2321-2016%22
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