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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Recall Number Z-1692-2013
Classification Class II
Code Info Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366
Product Distributed Qty 87 units
Reason For Recall DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.

Event Detail

Event Id 65554
Product Type Devices
Status Completed
Recalling Firm DeRoyal Industries Inc
City Powell
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-30
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern USA Nationwide Distribution in the state of PA
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