Stryker Precision Thin Blade Attachments Recalled for Measurement Failure
Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.
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: FDA Class II recall of medical device equipment with potential for malfunction (improper fitting preventing secure attachment). No hospitalizations, injuries, or illnesses have been reported, but the defect creates risk of harm during use.
Plain-English summary
Stryker Corporation is recalling 622 units of Precision Thin blade attachments (Catalog Number REF 2296-003-108) due to a potential measurement specification failure.
The blade attachments may not be within specified measurement tolerances, which could prevent them from fitting securely into the compatible handpiece. This potential defect was identified by the manufacturer.
The affected units, identified by Lot Number 22298017, were distributed worldwide. Healthcare facilities that have received these blade attachments should stop using them and contact Stryker Corporation for replacement or return instructions.
The recalled product
- Product
- stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
- Manufacturer
- Stryker Corporation
- Hazard
- improper-fit
- measurement-failure
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 04546540046482
- Lot Number 22298017
Distribution
Distribution scope not specified by the agency.
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