Paragon 28 recalls titanium suture anchors that may break during surgery, causing debris and delays. Affected kits include REF P44-110-3010-SK. Contact for return instructions.
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Paragon 28 is recalling titanium suture anchors that could break during surgery, potentially causing debris and delaying procedures. This affects surgeons and medical teams using the specific kit model.
The suture anchor may break when inserted into tissue, creating debris that can interfere with surgery and cause delays. This breakage risk occurs during normal surgical use, potentially affecting patient safety.
Surgeons and medical teams using the recalled Grappler Suture Anchor kit for surgical procedures are most at risk. Patients undergoing surgery with this specific device may face complications.
Check for the product name 'Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit' with reference number P44-110-3010-SK. The UDI-DI code 00889795114228 and lot number 5007499 identify affected units.
Identify the reference number P44-110-3010-SK and UDI-DI code 00889795114228 on the kit packaging.
Yes, the suture anchor may break during surgery, causing debris and delays that could affect patient safety.
Check for the reference number P44-110-3010-SK and UDI-DI code 00889795114228 on the kit packaging.
The recall record does not specify a remedy, so contact Paragon 28 directly for instructions.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-1776-2022 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-1776-2022 from Paragon 28. 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.
