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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Recall Number Z-1127-2013
Classification Class II
Code Info Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
Product Distributed Qty 100 kits
Reason For Recall Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.

Event Detail

Event Id 64646
Product Type Devices
Status Ongoing
Recalling Firm Synvasive Technology Inc
City El Dorado Hills
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Distribution in the state of IN
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