Z-0057-2021 Class II Terminated
FDA device recall Z-0057-2021 was initiated by Zimmer Biomet, Inc. on August 14, 2020 and is designated Class II. Reason for recall: The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. The recall status is terminated (terminated June 9, 2022). Affected quantity: 31.
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- August 14, 2020
- Termination Date
- June 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31
Product Description
Dual Mobility Vivacit-E Bearing, Model Number 110031009
Reason for Recall
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Distribution Pattern
Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV.
Code Information
Lot Number 64755636