Stryker AxSOS Drill Bit Recalled Due to Incorrect Scale
Stryker Orthopaedics is recalling AxSOS Calibrated Drill Bits because an incorrect scale may cause surgeons to select screws that are 10mm longer than intended.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (incorrect screw length) but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Orthopaedics is recalling the AxSOS Calibrated Drill Bit 4.3, X263mm, flat, manufactured by Stryker Osteosynthesis. The recall involves 107 units of the instrument, identified by catalog number 703615. The product is part of the AxSOS Locking Plate System, which is designed to treat periarticular or intraarticular fractures of the distal femur, proximal humerus, proximal tibia, and distal tibia.
The recall was initiated after Stryker Orthopaedics received a report indicating that the scale on the drill bit is incorrect. This defect could result in a surgeon selecting a locking screw that is 10mm longer than intended during the operative procedure.
The affected units were distributed nationwide, including in the states of Alabama, Arizona, Illinois, Kentucky, Louisiana, New Jersey, North Carolina, Florida, California, New Mexico, Missouri, Tennessee, Virginia, Colorado, Massachusetts, Texas, Indiana, and Montana. Healthcare facilities and providers who have received these instruments should contact Stryker Orthopaedics for instructions on how to return or replace the affected units.
The recalled product
- 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
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 107
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number 703615
Distribution
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