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Use caution Medical device recall · FDA · Published January 29, 2025

Stryker CinchLock Anchor Recall: Pullwire Breakage Risk

Stryker recalls CinchLock Flex Knotless Anchor with Inserter due to reported pullwire breakage that may leave broken wire inside the implant body after surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1328-2025Medical deviceStryker ›
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Contact the company

Recalling firmStryker Corporation5900 Optical Ct · San Jose, CA 95138-1400
✎ GovInfoNow plain-language explainer

Stryker is recalling a specific surgical anchor product because complaints indicate the pullwire can break during use, potentially leaving broken wire inside the implant body. This poses a risk of retained foreign material after surgery. Read more at govinfonow.com/recall/53015-stryker-cinchlock-anchor-recall-pullwire-breakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53015-stryker-cinchlock-anchor-recall-pullwire-breakage-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1328-2025

Cite this page

“Stryker CinchLock Anchor Recall: Pullwire Breakage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53015-stryker-cinchlock-anchor-recall-pullwire-breakage-risk. Based on FDA recall #Z-1328-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2025%22&limit=1).

The FDA announced on Jan. 29, 2025, that Stryker Corporation is recalling its CinchLock Flex Knotless Anchor with Inserter and Suture due to pullwire breakage hazards. The recall affects approximately 9,521 units distributed worldwide.

How to tell if you have it

  • Brand: Stryker
  • Product: Stryker CinchLock Flex Knotless Anchor with Inserter and Suture
  • REF: CAT02643
  • Lot codes: 23342AE2, 24190AE2, 23345AE2, 24200AE2, 24004AE2, 24201AE2, 24008AE2, 24204AE2, 24009AE2, 24205AE2, 24010AE2, 24206AE2, 24032AE2, 24214AE2, 24033AE2, 24215AE2, 24036AE2, 24221AE2, 24050AE2, 24222AE2, 24061AE2, 24226AE2, 24064AE2, 24233AE2, 24065AE2, 24235AE2, 24066AE2, 24240AE2, 24087AE2, 24248AE2, 24093AE2, 24249AE2, 24094AE2, 24250AE2, 24127AE2, 24256AE2, 24128AE2, 24257AE2, 24135AE2, 24258AE2, 24136AE2, 24260AE2, 24137AE2, 24276AE2, 24143AE2, 24277AE2, 24144AE2, 24278AE2, 24159AE2, 24283AE2, 24160AE2, 24284AE2, 24162AE2, 24285AE2, 24169AE2, 24292AE2, 24170AE2, 24306AE2, 24184AE2, 24309AE2, 24185AE2, 24311AE2, 24186AE2, 24312AE2

The hazard

According to the FDA, there is an increase in complaints concerning pullwire breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

Context

GovInfoNow's records show Stryker Corporation has 34 other recalls on record since Nov. 17, 2017. Other recent recalls include a June 8, 2026 recall for leaking handpieces and a May 6, 2026 recall for an electrical shock risk in the Neptune Smart Docking Station. Similar product recalls reported on Dec. 17, 2025, include risks of anchor breakage for Aju Pharm Genesis Dual Thread Screw-In Anchor, Genesis Knotless Anchor, and Genesis Screw-In Anchor.

How to tell if you have this one

Check for the product name 'Stryker CinchLock Flex Knotless Anchor with Inserter and Suture' with the reference number CAT02643 and sterile packaging. The lot numbers listed in the recall include specific codes like 23342AE2 through 24312AE2.

  • Brand
    Stryker
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by its reference number CAT02643 and check if your surgical implant matches the listed lot numbers.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 46 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: 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.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Jan 29, 202512. FDA classified it Class II: Mar 12, 202523. Published in FDA’s Enforcement Report: Mar 19, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1328-2025 (January 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1328-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA