Device product
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Z-2519-2023
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 92889
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-2519-2023
Official wording
Reason: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Code information: Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215
Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
Derived failure modes
-
Unknown
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.