FDA recall Z-1985-2026

DEPUY (IRELAND) · Class II · device

Product

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

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.

Key facts

Status
Ongoing
Initiation date
2026-04-03
Report date
2026-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Co. Cork, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1985-2026