FDA Device recall Z-0909-2024
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement by Howmedica Osteonics, citing product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0909-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-01 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
Reason
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Identifiers
| code_info | GTIN: 04546540306104 Lot Numbers: 42579701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0909-2024%22
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