FDA Device recall Z-2732-2024
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific)
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific) by Howmedica Osteonics, citing A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2732-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-05 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | n/a |
Product
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Reason
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Identifiers
| code_info | Catalog Number: C-MM100434-00; Lot Number: HX2H9A; |
|---|
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-2732-2024%22
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