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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Detail

Product Description Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Recall Number Z-2284-2013
Classification Class II
Code Info REF: 1150000 Lot: 0207029284
Product Distributed Qty 60
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.

Event Detail

Event Id 66355
Product Type Devices
Status Completed
Recalling Firm Medtronic Xomed, Inc.
City Jacksonville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-23
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide Distribution (US), including the states of CA, NE, GA, and IL.