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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. REF: 1150000 Lot: 0207029284 Class II One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. 60 Z-2284-2013