Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2284-2013 — Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.

U.S. FDA — Device Enforcement · United States · 2013-08-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2284-2013
Date of alert
2013-08-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Xomed, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0207029284
Reported risk: One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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