Recall Z-1328-2025— Stryker Corporation

Name: FDA recall Z-1328-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-29

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2025-01-29. It names one FDA 510(k) clearance: K151314. Product: Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197. Reason: Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-01-29
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K151314 — CinchLock Flex Knotless Suture AnchorPivot Medical·cleared 2015-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

Reason for recall

Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

Data sourced from openFDA. This site is unofficial and independent of the FDA.