DePuy Mitek recalls Healix Knotless ADV BR 4.75 Suture Anchors made with BIOCRYL Biocomposite Material instead of BIOCRYL RAPIDE. This could affect implant fixation in sports medicine procedures.
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 4.75 Suture Anchors that were made with BIOCRYL Biocomposite Material instead of the intended BIOCRYL RAPIDE. This could affect the anchor's performance during sports medicine procedures.
The recalled anchors were manufactured with BIOCRYL Biocomposite Material instead of BIOCRYL RAPIDE. This difference in material could affect the anchor's performance during implant fixation procedures in sports medicine.
Patients who received the recalled suture anchors during sports medicine procedures are likely affected. Surgeons and medical facilities using these anchors for implant fixation are at risk.
Check for the product code: Healix Knotless ADV BR 4.75 Suture Anchor with Part Number 222330 and Batch/Lot 5L45257. The GTIN is 10886705023462.
Identify the product code, batch number, and GTIN to confirm if your anchor is recalled.
The recall states the anchors were made with the wrong biocomposite material, but the specific risk level is not clearly described in the notice.
The recall notice does not provide specific action steps for affected users.
Check for the product code: Healix Knotless ADV BR 4.75 Suture Anchor with Part Number 222330 and Batch/Lot 5L45257.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-0665-2020 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-0665-2020 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.
