Offset Cup Impactor - 3/8-16 interface. Reusable recall
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Why was Offset Cup Impactor - 3/8-16 interface. Reusable recalled?
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
- Product
- Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
- Recalling firm
- INCIPIO DEVICES
- Quantity
- 100 units
- Distribution
- US Nationwide distribution in the state of TN.
- Recall date
- December 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)