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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Recall Number Z-2099-2013
Classification Class II
Code Info Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit
Product Distributed Qty 23 units
Reason For Recall Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.

Event Detail

Event Id 65891
Product Type Devices
Status Ongoing
Recalling Firm Stryker Howmedica Osteonics Corp.
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution in the states of: FL. OH, TX, & VA