DePuy Mitek recalls Healix Knotless ADV BR 5.5 Suture Anchors made with BIOCRYL Biocomposite instead of BIOCRYL RAPIDE. This could affect implant fixation safety. Check product codes for affected items.
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
DePuy Mitek is recalling Healix Knotless ADV BR 5.5 Suture Anchors that were made with BIOCRYL Biocomposite material instead of BIOCRYL RAPIDE. This could affect the safety of the implant fixation in sports medicine procedures.
The suture anchors were manufactured with BIOCRYL Biocomposite material instead of the intended BIOCRYL RAPIDE material. This difference in material could affect the implant fixation safety during sports medicine procedures.
Patients who received these specific suture anchors during surgery are likely affected. Surgeons and medical facilities using these anchors for sports medicine procedures are at risk.
Check for product codes: Part Number 222331, Batch/Lot 5L45259 or 5L13543, and GTIN 10886705023479. These specific items were manufactured with the wrong material.
Identify if your suture anchor has the specific part number 222331 and batch/lots 5L45259 or 5L13543.
The suture anchors were manufactured with BIOCRYL Biocomposite material instead of the intended BIOCRYL RAPIDE material, which could affect implant fixation safety.
Check your suture anchor for the specific part number 222331 and batch/lots 5L45259 or 5L13543. If it matches, contact DePuy Mitek for further instructions.
The recall record does not specify if there have been injuries or if the product poses a risk of injury in normal use.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-0666-2020 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-0666-2020 from DePuy Mitek. 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.
