FDA recall Z-0338-2020
Zimmer Biomet, Inc. · Class II · device
Product
cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution
Distributed nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2019-10-10
- Report date
- 2019-11-13
- Termination date
- 2020-05-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Warsaw, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0338-2020