Warning
DEPUY (IRELAND) Recalls Depuy Synthes
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1989-2026Medical Device
DEPUY (IRELAND) Recalls Depuy Synthes
DEPUY (IRELAND) · Class II — Moderate Risk
Product Description
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Reason for Recall
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of MN, NC, TX.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database