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Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used i
Recalled November 28, 2012 · FDA recall Z-0388-2013 · Stryker Howmedica Osteonics
Hazard
Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw. · FDA Class II
Units
Approximately 358 units
Sold at
Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.
Description
Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
Product
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
Manufacturer(s)
Stryker Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →