Z-0837-2018 Class II Terminated
FDA device recall Z-0837-2018 was initiated by Stryker Corporation on November 17, 2017 and is designated Class II. Reason for recall: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. The recall status is terminated (terminated January 29, 2024). Affected quantity: 60,753 units total.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- November 17, 2017
- Termination Date
- January 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,753 units total
Product Description
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Reason for Recall
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Distribution Pattern
Distributed domestically to . Distributed internationally to Australia and Mexico.
Code Information
Model 0234010056, UDI 04546540754561, Lot No. 17278AG2