Class II — DePuy Mitek, Inc., a Johnson & Johnson Co.
| Recalling firm | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
|---|---|
| Registered facility | DePuy Mitek, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Healix Knotless ADV BR 4.75 Suture Anchor |
| Quantity | 299 |
| Distribution | US: AL AZ CA CT FL IA IL IN LA MA MD ME MI MN MT NC NE NH NJ NM OH OK OR PA TN TX VA WA WI International: Belgium, Chile, China, Czech Republic, France, India, Japan, Korea, Latvia, New Zealand, Slovakia Sweden |
| Initiated | 2019-11-04 |
| Classified | 2019-12-10 |
| Terminated | 2020-05-05 |
| Recall number | Z-0665-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Mitek, Inc., a Johnson & Johnson Co. (Z-0665-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84237/
Alerts for DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.