Stryker Recalls CinchLock Knotless Anchors Due to Internal Wire Breakage
Stryker is recalling CinchLock Knotless Anchors after 13 reports of internal wire breakage upon deployment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text reports 13 instances of device failure (internal wire breaking) upon deployment, which constitutes a significant injury risk consistent with the 'Severe' rubric criteria.
Plain-English summary
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter. The recall is being conducted after 13 reports of an internal wire breaking upon deployment of the anchor.
The affected devices are non-degradable implant devices intended for the fixation of soft tissue to bone. They are used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee. The recall includes 3,100 total devices across both models.
The devices were distributed in the United States (nationwide) as well as in Australia, Switzerland, the Netherlands, Spain, and Sweden. Specific model numbers and serial numbers are identified in the recall documentation.
The recalled product
- Product
- CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used fo
- Manufacturer
- Stryker Corporation
- Affected units
- 3,100
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 (4)
- Model number: CAT02643
- Serial numbers: 15122202
- 16011301
- 16020802
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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