FDA Medical Device Recalls (openFDA)
Stryker Corporation: 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 repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
- Recall number
- Z-1634-2016
- Recalling firm
- Stryker Corporation
- 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 repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
- Status
- Terminated
- Initiated
- 2016-04-12
- Posted
- not on file
- Terminated
- 2016-12-12
- Reason
- Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.
- Root cause
- Device Design
- Action
- Urgent Medical Device Recalls letters were sent on April 12, 2016 to US customers by certified mail. Stryker International distribution sites will be notified by e-mail. Letters describe the reason for recall with the affected part and lot numbers. Any recalled product should be segregated and returned to Stryker.
- Quantity
- 3100 total device, both model numbers.
- Distribution
- Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
- Lot, serial or model codes
- Model number: CAT02462 Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.
- 510(k) numbers
- ["K131769"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28