Z-1635-2016Class II

CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS...

Name: Z-1635-2016 CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS...
Creator: Stryker Corporation
Published: 2016-04-12
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-04-12 / Terminated / root cause: design

FDA source

Stryker Corporation began a recall of CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex... on 2016-04-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1635-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-12
Posted: 2016-05-10
Terminated: 2016-12-12
Recalling firm: Stryker Corp.
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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: 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.
Root cause tag: design
FDA 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 in commerce: 3100 total devices, both models
Distribution: Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
Product codes and lots: Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1635-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1634-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-10
Z-1635-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-10

Product code MBI

K151314Class IICinchLock Flex Knotless Suture AnchorPivot Medical / cleared 2015-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)