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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM

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 Class 2 Device Recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEMsee related information
Date Initiated by FirmApril 03, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1991-2026
Recall Event ID 98707
510(K)NumberK242871 
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
ProductDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Code Information Part Number: 150450205. UDI-DI: 10603295533160. Lot Number: 1006444. Expiration Date: 10/31/2035.
FEI Number 3002854251
Recalling Firm/
Manufacturer		 DEPUY (IRELAND)
Loughbeg, Ringaskiddy
Co. Cork Ireland
For Additional Information ContactKimberly Long
574-221-8156
Manufacturer Reason
for Recall		The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA Determined
Cause 2		Under Investigation by firm
ActionDepuy Ireland notified consignees on about 04/03/2026 via email. Consignees were instructed to examine inventory for affected units and immediately quarantine them, arrange for the return of all affected units, and complete and return the provided Business Response Form. Consignees were also instructed to forward the notification letter to anyone within each facility that needs to be informed, notify customers if affected units were further distributed and post a copy of the notification letter in a visible area for awareness.
Quantity in Commerce3 units
DistributionUS Nationwide distribution in the states of MN, NC, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KRO
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