The Recall Desk
SevereFDA (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.

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 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 for
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 →