Device product
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Z-0838-2018
Product summary
- Event
- Event 78668
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60,753 units total
- Official record key
device-enforcement:Z-0838-2018
Official wording
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.
Code information: Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
Distribution pattern: Distributed domestically to . Distributed internationally to Australia and Mexico.
Derived failure modes
-
Microbial contamination
bioburden testing of certain lots were found