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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 - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument
Recall Number Z-1635-2013
Classification Class II
Code Info 122347, 122289, 122322, 122511.
Product Distributed Qty 10
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.