FDA-Device2013-05-08Class II
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 cor
Stryker Howmedica Osteonics Corp.
Hazard
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.
Sold states
Nationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT.
Affected count
107 units
Manufactured in
325 Corporate Drive, Mahwah, NJ, United States
Products
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."
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1210-2013Don't want to check this manually?
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