Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Reported: March 19, 2025 Initiated: January 29, 2025 #Z-1328-2025
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.
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 9521 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Colombia, Netherlands, Spain, Mexico, Australia, United Kingdom, Brazil.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197. Recalled by Stryker Corporation. Units affected: 9521 units.
Why was this product recalled? ▼
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2025. Severity: Moderate. Recall number: Z-1328-2025.
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