CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Custom Made Device - Gmrs Extension Piece Left recalled
Howmedica Osteonics is recalling Custom Made Device - Gmrs Extension Piece Left, 35 Deg Ext Rotated Tabs (Patient Specific). The recall was initiated on 5 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2732-2024
- FDA event ID
- 95114
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2024
- FDA classified
- 26 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Aug 2024 | Recall initiated by company | |
| 26 Aug 2024 | Classified by FDA | +21 days |
| 4 Sep 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Product as listed by the FDA
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Where it was distributed
International distribution to the country of Australia.
Questions about this recall
Why was it recalled?
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Which lots are affected?
Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
Where was it sold?
International distribution to the country of Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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