Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Recalled by Stryker Howmedica Osteonics Corp. Due to Stryker Orthopaedics has received a report indicating that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Howmedica Osteonics Corp. directly.
Affected 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."
Quantity: 107 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Corp. has 87 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report