FDAClass IIMay 18, 2016

CinchLock SS Knotless Anchor with Inserter recall

CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock…

Why was CinchLock SS Knotless Anchor with Inserter recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock…
Recalling firm
Stryker Corporation
Quantity
3100 total device, both model numbers.
Distribution
Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
Recall date
May 18, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls