Agency classClass IIOur severity:Severe FDA (Devices)·Z-1634-2016·Announced 2016-05-18

Stryker Recalls CinchLock SS Knotless Anchor Due to Wire Breakage

Stryker is recalling CinchLock SS Knotless Anchors after 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 involves a structural defect (wire breakage) in an implanted medical device, which poses a risk of significant injury or requires additional surgery, meeting the criteria for a Severe rating.

Plain-English summary

Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter. These are non-degradable implant devices intended for the fixation of soft tissue to bone, used for repair of the hip, shoulder, foot and ankle, elbow, wrist and hand, and knee.

The recall was initiated after 13 reports of an internal wire breaking upon deployment of the anchor. The affected devices include model numbers CAT02462 and CAT02463. A total of 3,100 devices were distributed.

The devices were distributed in the United States (nationwide) as well as in Australia, Switzerland, the Netherlands, Spain, and Sweden. Affected serial numbers for model CAT02462 are 15120801, 15121401, 16010402, 16011901, and 16012501. Healthcare providers and patients should contact Stryker Corporation for further instructions on the recall.

The recalled product

Product: CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; 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: structural-failure
implant-defect
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 (5)

Model number: CAT02462 Serial numbers: 15120801
15121401
16010402
16011901
16012501.

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

See all →

High
Stryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
High
Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
Severe
Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
High
Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
High
Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12

Same hazard · structural failure