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
- Recall Initiated
- November 9, 2016
- Terminated
- March 27, 2019
- Recall Number
- Z-0880-2017
- Quantity
- 2,084 units
- Firm Location
- Mahwah, NJ
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.
Distribution
Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.
Lot / Code Info
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
Root Cause
Packaging process control
Action Taken
Stryker sent an Urgent Medical Device Removal letter dated November 9, 2016, to all affected customers via UPS (with return receipt). Stericycle will be handling the returns. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inform users of the Medical Device Recall and forward the notice to all those individuals who need to be aware within their organization. Return all affected products available at their location to: Stryker C/O Stericycle 2670 Executive Dr., Suite A Indianapolis, IN 46241 Attn: RA 2016-169 - Event XXX Customers were also instructed to complete and sign the enclosed Business Reply Form and return to Stericycle. Customers with questions should call +1-201-851-6683. For questions regarding this recall call 201-831-5000.