FDA Device recall Z-2519-2023
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
- FDA Device
- Class II
- ongoing
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class II recall of M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440) by Zimmer, citing the outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2519-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-26 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zimmer |
| Distribution | US |
Product
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Reason
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Identifiers
| code_info | Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2519-2023%22
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