Healix Knotless ADV BR 5 — Class II medical device recall Z-0666-2020
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2019-12-18, distributed in AL, AZ, CA, CT, FL, IA, IL, IN…. Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL"
| Recall number | Z-0666-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Norwood, MA, United States |
| Recall initiated | 2019-11-04 |
| Classified | 2019-12-10 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2020-05-05 |
| Distributed | 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 |
| Countries outside the US | BE, CL, CN, CZ, FR, IN, JP, KR, LV, NZ, SE, SK |
| Quantity | 599 |
| UPC / GTIN / UDI-DI | 10886705023479 |
| Lot numbers | 5L13543, 5L45259 |
| Model numbers | 222331 |
Product
Healix Knotless ADV BR 5.5 Suture Anchor
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0666-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.