Recall Z-0838-2018— Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Corporation, initiated 2017-11-17, terminated 2024-01-29. FDA's recall record names no specific 510(k) clearance for this event. Product: ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.. 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..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-17
- Terminated
- 2024-01-29
- Firm location
- San Jose, CA, United States
Product description
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.