Z-0838-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- November 17, 2017
- Termination Date
- January 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,753 units total
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.
Distribution Pattern
Distributed domestically to . Distributed internationally to Australia and Mexico.
Code Information
Model 0234020280, UDI 07613154643264, Lot No. 17299AG2