FDAClass IIMay 6, 2026

Depuy Synthes recall: Sterility Concern

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

Why was Depuy Synthes recalled?

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

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?

Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441, AF1008028. Expiration Date: 12/31/2035.

Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Recalling firm
DEPUY (IRELAND)
Quantity
3 units
Distribution
US Nationwide distribution in the states of MN, NC, TX.
Recall date
May 6, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls