Recall Z-1210-2013— Stryker Howmedica Osteonics Corp.

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-03-28, terminated 2015-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve.". Reason: Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended..

Recalling firm

Stryker Howmedica Osteonics Corp.

Classification

Class II

Status

Terminated

Initiated

2013-03-28

Terminated

2015-11-17

Firm location

Mahwah, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.