Stryker Precision Thin surgical blade attachments recalled for specification defect
Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.
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: This medical device recall involves a functional specification defect on a surgical instrument. Although no injuries have been reported and the issue is classified as FDA Class II (not Class I), the improper fit of a surgical blade represents a risk of harm that warrants a High severity rating even without documented incidents.
Plain-English summary
Stryker Corporation is recalling 238 units of its Precision Thin surgical blade attachments (Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades) due to a potential specification defect.
The recalled blade attachments may be out of measurement specifications, preventing them from fitting securely into their compatible surgical handpieces. This defect could affect the proper functioning and safety of the instrument during surgical use.
These products were distributed worldwide. Units are identified by GTIN 04546540466549 and Lot Number 23070017. Healthcare facilities and providers who received these blade attachments should identify affected units by the lot number and take them out of service. Contact Stryker Corporation for instructions on product return or replacement.
The recalled product
- Product
- stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
- Manufacturer
- Stryker Corporation
- Hazard
- improper-fit
- specification-defect
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 (2)
- GTIN 04546540466549
- Lot Number 23070017
Distribution
Distribution scope not specified by the agency.
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