FDA Device recall Z-1635-2016
CinchLock Flex Knotless Anchor with Inserter
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of CinchLock Flex Knotless Anchor with Inserter by Stryker, citing stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deploy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1635-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-12 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker |
| Distribution | US |
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 for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
Reason
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.
Identifiers
| code_info | Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1635-2016%22
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