Z-1011-2018 Class II Terminated
FDA device recall Z-1011-2018 was initiated by Zimmer Biomet, Inc. on October 3, 2017 and is designated Class II. Reason for recall: The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur. The recall status is terminated (terminated August 23, 2018). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- October 3, 2017
- Termination Date
- August 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Reason for Recall
The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
Distribution Pattern
US Distribution to states of: FL, WI, MD, MO, and MI.
Code Information
Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900