Stryker CinchLock anchor recalled due to pullwire breakage
Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.
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 3/5 (High).
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 with no reported injuries or illnesses. The hazard is a device-failure risk (pullwire breakage in a surgical implant) that could compromise the anchor's intended function, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Stryker Corporation is recalling 9,521 units of its CinchLock Flex Knotless Anchor with Inserter and Suture (REF CAT02643) worldwide due to an increase in complaints concerning pullwire breakage.
The pullwire is a critical component used during the anchor deployment procedure. When breakage occurs, the broken pullwire may remain in the anchor implant body after deployment, which could potentially affect device performance or require additional intervention.
The recall affects units distributed in the United States (all states plus Puerto Rico) and internationally (Argentina, Colombia, Netherlands, Spain, Mexico, Australia, United Kingdom, and Brazil). Affected lot numbers range from 23342AE2 to 24312AE2.
Patients and healthcare providers who have received or are considering this device should contact Stryker Corporation or their device distributor for further guidance and recall instructions.
The recalled product
- Product
- Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Surgical Anchor
- Affected units
- 9,521
Distribution
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