Recall Z-2912-2018 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Stryker Leibinger GmbH & Co. KG
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
| Date | Jun 22, 2018 |
| Status | Terminated |
| Reason | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
| Root cause | Package design/selection |
| Action | URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken: 1. Please inform users of this Medical Device Removal and pass this notice to all appropriate individuals within your organization. 2. Return all affected products available at your location to: Stryker CMF Attn: Recall Coordinator 6300 Sprinkle Rd Portage, MI 49002 REF: PFA #1739180 Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us. 3. Complete and sign the enclosed Business Reply Form and fax a copy t |
| Quantity | 22,831 total |
| Distribution | US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120352 | STRYKER QUIKFLAP STERILE PROCEDURE PACK Stryker, Jun 11, 2012 |