Device product
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Z-0837-2018
Product summary
- Event
- Event 78668
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60,753 units total
- Official record key
device-enforcement:Z-0837-2018
Official wording
Reason: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Code information: Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
Distribution pattern: Distributed domestically to . Distributed internationally to Australia and Mexico.
Derived failure modes
-
Microbial contamination
bioburden testing of certain lots were found