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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
Recall Number Z-1637-2013
Classification Class II
Code Info 122518, 122447.
Product Distributed Qty 4
Reason For Recall The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Event Detail

Event Id 65205
Product Type Devices
Status Ongoing
Recalling Firm Surgical Instrument Service And Savings, Inc.
City Redmond
State OR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.