FDA Device recall Z-0880-2017
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Ge…
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Ge… by Stryker Howmedica Osteonics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0880-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-09 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
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
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.
Identifiers
| code_info | GAM Kirschner Wire - Manufacturing Part Number 12106450S, Lot #'s K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0,…GAM Kirschner Wire - Manufacturing Part Number 12106450S, Lot #'s K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0, K081720, K081721, K0810872, K081723, K081727, K082C8B, K084F89, K084F98, K08683D, K08683E, K086841, K08820B, K089AF5, K08E1E1, K0911F4, K09379B, K096A26, K096A2A, K09A2C, K098213, K098215, K099AA0, K09AD33, K09BA4F, K09D564, K09F026, K0A1EF8, K0A1EFA, KoA1EFB, K0A38FB, K0A63AB, K0A63AC and K0A7BC1 T2 K-Wire - Manufacturing Part Number 18060050S, Lot #'s K084FBF, K0920A4, K0A1EFD, K093747, K0937C4, K09BA53, K09BA54, K09BA55 and K09BA56 T2 K-Wire Recon - Manufacturing Part Number 18063030S, Lot #'s K086847, K08E1E9 and K099AA8 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Stryker Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0880-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.