—#120729

Product

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 product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K000080
Affected lot / code info: Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit

Why it was recalled

Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: USA Nationwide Distribution in the states of: FL. OH, TX, & VA

Timeline

Recall initiated: 2013-07-08
Posted by FDA: 2013-08-27
Terminated: 2015-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.