ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, 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-0838-2018
- 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. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.
Distribution
Distributed domestically to . Distributed internationally to Australia and Mexico.
Lot / Code Info
Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
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.