Stryker Recalls Cancellous Bone Screws Due to Packaging Error
Stryker is recalling specific Cancellous Bone Screws because a 5.5 mm screw was found in packaging labeled for a 6.5 mm screw.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging/labeling error where a different size screw was found in the wrong packaging. No injuries or illnesses are reported in the source text, and the risk is theoretical until the wrong size is used, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling specific lots of Cancellous Bone Screws. The recall involves 4 units of the 6.4 mm diameter, 25 mm length screw (Catalog No. 2030-6525-1, Lot MMLNLA) and 7 units of the 5.5 mm diameter, 40 mm length screw (Catalog No. 2029-5540-1, Lot MMLMJ1). These devices are cleared for use in Total Hip Arthroplasty and Total Knee Arthroplasty as supplemental fixation.
The recall was initiated after Stryker received a field report indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm. This indicates a potential packaging or labeling error where the wrong size screw may have been placed in the wrong package.
The affected products were distributed nationwide. Healthcare providers and facilities that have received these specific catalog numbers and lot codes should stop using the devices and contact Stryker for instructions on return or replacement. Patients who have already had these specific screws implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
Distribution
Distributed nationwide across the United States.
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