GAM Kirschner Wire — Class II medical device recall Z-0880-2017
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-12-28, distributed nationwide. A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is
| Recall number | Z-0880-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2016-11-09 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2019-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 2,084 units |
| Reason classes | sterility, packaging |
| Lot numbers | K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0, K0810872, K081720, K081721, K081723, K081727, K082C8B, K084F89, K084F98, K084FBF, K08683D, K08683E, K086841, K086847, K08820B, K089AF5, K08E1E1, K08E1E9, K0911F4, K0920A4, K093747, K09379B, K0937C4, K096A26, K096A2A, K098213, K098215, K099AA0, K099AA8, K09A2C, K09AD33, K09BA4F, K09BA53, K09BA54, K09BA55 and 11 more |
| Model numbers | 12106450S, 18060050S, 18063030S |
Product
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
Reason for recall
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
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-0880-2017. 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.