Recall Z-1250-2018 ยท LOD Bone Cement
Stryker Instruments Div. of Stryker Corporation
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
| Date | Nov 9, 2017 |
| Status | Terminated |
| Reason | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| Root cause | Environmental control |
| Action | Letters dated November 16, 2017, were sent to customers. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Business Reply Form (BRF). 5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 6. Return the completed BRF to Str |
| Quantity | 1244 |
| Distribution | Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032945 | SIMPLEX X Stryker Corp., May 25, 2004 |