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.
FDA Recall Z-2099-2013 · Posted 2013-08-27
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWC
Date Initiated2013-07-08
Date Terminated2015-03-31
Product Quantity23 units
Reason for Recall
Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
Firm Action
Stryker sent an Urgent Medical Device Removal letter dated July 8, 2013 via Fed Ex to all affected customers. The letter identified the affected product, product issues, potential hazards, risk mitigation and actions to be taken. Customers were instructed to return all affected products available to Stryer Osteosynthesis or contact Stryer customer service and complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-251-3635. Questions can be directed to Stryker at 201-972-2100.
Root Cause
Process control
Distribution Pattern
USA Nationwide Distribution in the states of: FL. OH, TX, & VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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