STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
This recall has been terminated (originally issued November 17, 2017).
- Company
- Stryker Corporation
- Recall Initiated
- November 17, 2017
- Terminated
- January 29, 2024
- Recall Number
- Z-0837-2018
- Quantity
- 60,753 units total
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Distribution
Distributed domestically to . Distributed internationally to Australia and Mexico.
Lot / Code Info
Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
Root Cause
Under Investigation by firm
Action Taken
On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.