Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Summary
The FDA issued a Class II for Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204 by DEPUY (IRELAND). Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility..
Details
Source
Device Recall
External ID
Z-1990-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Lot/Code Info: Part Number: 150450204. UDI-DI: 10603295533153. Lot Number: 1005229. Expiration Date: 10/31/2035.
Quantity Affected: 3 units
Reason for Recall
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Distribution
US Nationwide distribution in the states of MN, NC, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-03
Company
Co. Cork
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DEPUY (IRELAND) has 10 FDA actions in our database, including 9 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DEPUY (IRELAND)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DEPUY (IRELAND) have FDA actions?
DEPUY (IRELAND) has 10 FDA actions in our database, including 9 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1990-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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