Agency classClass IIOur severity:Severe FDA (Devices)·Z-1635-2016·Announced 2016-05-18

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Stryker Corporation
Category: Medical Device — Orthopedic Implant
Hazard: device-failure
implant-malfunction
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.

See all 2 products in this recall →

Same manufacturer · Stryker Corporation

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