CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
Offset Cup Impactor - 3/8-16 interface recalled by Incipio Devices
Incipio Devices is recalling Offset Cup Impactor - 3/8-16 interface, distributed nationwide in the US. The recall was initiated on 30 Oct 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-0549-2025
- FDA event ID
- 95653
- Recalling firm
- Incipio Devices, St-Blaise
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2024
- FDA classified
- 25 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 30 Oct 2024 | Recall initiated by company | |
| 25 Nov 2024 | Classified by FDA | +26 days |
| 4 Dec 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
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Where it was distributed
US Nationwide distribution in the state of TN.
Questions about this recall
Why was it recalled?
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Which lots are affected?
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Where was it sold?
US Nationwide distribution in the state of TN.
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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