TWIST DR 25X95MM Cann 12MM Thd 30MM AO — Class II medical device recall Z-2321-2016
Terminated recall by Zimmer Gmbh, reported 2016-08-10, distributed in CO, IL. Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolera
| Recall number | Z-2321-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Gmbh, Winterthur, Switzerland |
| Recall initiated | 2016-06-27 |
| Classified | 2016-08-02 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-05-30 |
| Distributed | CO, IL |
| Countries outside the US | AE, AR, AU, BE, BR, CA, CH, CN, CO, CR, DE, DO, EC, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IR, IT, JM, JO, JP, KR, LB, MT, MX, MY, NL, NO, NZ, PH, PT, RU, SA, SE, SG, SV, TH, TR, TW, UY, VE, VN |
| Quantity | 169 |
| Lot numbers | 10413/311A12, 11137/188B12, 8695/188B11, 8916/188B11, 9555/188D11 |
| Model numbers | 502015621 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2321-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.