Offset Cup Impactor - 3/8-16 interface. Reusable surgical… recallZ-0549-2025 · Incipio Devices · initiated Oct 30, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Incipio Devices or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
FDA root cause category: Process change control
What the company is doing
Consignees were mailed a recall notification titled URGENT ADVISORY NOTICE dated 10/30/2024. The notification instructs consignees to examine their inventory and identify all affected devices for quarantine immediately. Consignees are to complete and return the Recall Response Form to Incipio Devices at [email protected] to facilitate the return of recalled devices and issuance of a FedEx return label. Returned devices should be sent back in their original packaging if unused and properly decontaminated and sterilized if being sent back used. Consignees with any questions should contact Incipio Devices by phone at +41 32 754 34 34 or by email at [email protected].
Recall details
- Recall number
- Z-0549-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 30, 2024
- Posted by the FDA
- Nov 25, 2024
- Recalling firm
- Incipio Devices
- Quantity
- 100 units
- Product code
- HWA
- Distribution
- US Nationwide distribution in the state of TN.
Product description
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Code information (models, lots, serial numbers)
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Offset Cup Impactor - 3/8-16 interface 50341105Incipio Devices SA · Impactor1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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