Recall Z-0838-2018 ยท KDD Kit, Surgical Instrument, Disposable
Stryker Corporation
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
| Date | Nov 17, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 60,753 units total |
| Distribution | Distributed domestically to . Distributed internationally to Australia and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.