Stryker recalls CinchLock Flex Knotless Anchor with Inserter due to reported pullwire breakage that may leave broken wire inside the implant body after surgery.
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
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.
The pullwire in the anchor can break during deployment, which may leave broken wire inside the implant body. This could cause complications such as infection or additional surgery to remove the retained wire.
Patients who received the recalled anchor during surgery are most at risk. Healthcare providers using this product for surgical procedures may also be affected.
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.
Identify the product by its reference number CAT02643 and check if your surgical implant matches the listed lot numbers.
The recall indicates reported pullwire breakage that may leave broken wire inside the implant body after surgery, so it is not recommended for use.
Check for the reference number CAT02643 and the specific lot numbers listed in the recall, such as 23342AE2 through 24312AE2.
The recall does not specify a remedy, so contact Stryker directly for guidance on next steps.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1328-2025 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1328-2025 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
