INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip… recallZ-1753-2024 · Innomed, Inc. · initiated Mar 7, 2024
Completed
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 Innomed, Inc. 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
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
FDA root cause category: Under Investigation by firm
What the company is doing
Innomed issued an urgent medical device recall notice to its consignees on 03/07/2024 via email. The notice explained the issue, potential risk to health, and requested the return of the affected devices for US distribution and destruction of the affected devices distributed outside the US.
Recall details
- Recall number
- Z-1753-2024
- Status
- Completed
- Initiated by the company
- Mar 7, 2024
- Posted by the FDA
- May 1, 2024
- Recalling firm
- Innomed, Inc.
- Quantity
- 41 devices
- Product code
- HWB
- Distribution
- FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Product description
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Code information (models, lots, serial numbers)
UDI/DI 00840277104007, Lot Number 1223K
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Innomed, Inc. 5200-54Innomed, Inc. · Extractor1 recall0 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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