FDA Device recall Z-0666-2020
Healix Knotless ADV BR 5.5 Suture Anchor
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Healix Knotless ADV BR 5.5 Suture Anchor by Depuy Mitek A Johnson And Johnson, citing specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Materia….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0666-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-04 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Depuy Mitek A Johnson And Johnson |
| Distribution | 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 |
Product
Healix Knotless ADV BR 5.5 Suture Anchor
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.
Identifiers
| code_info | Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Depuy Mitek A Johnson And Johnson
- COR Disposable Kit, 8 mm w/ Perpendicularity
FDA Device · Class II · 2025-03-19 · Depuy Mitek A Johnson And Johnson - COR Disposable Kit, 8 mm
FDA Device · Class II · 2025-03-19 · Depuy Mitek A Johnson And Johnson - DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliz…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson - DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliza…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson - DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilizat…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson
All Depuy Mitek A Johnson And Johnson recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0666-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.