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Terminated

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

FDA Recall Z-2284-2013 · Posted 2013-09-26

Recalling FirmMedtronic Xomed, Inc.
Recall StatusTerminated
Product CodeETA
Date Initiated2013-08-23
Date Terminated2013-11-07
Product Quantity60

Reason for Recall

One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

Firm Action

An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution (US), including the states of CA, NE, GA, and IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002897TITANIUM MIDDLE EAR PROSTHESESXomed, Inc. · 2000-10-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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