CLASS II Device recall · Reported 18 Dec 2019 · FDA Enforcement Report

Healix Knotless ADV BR 4.75 Suture Anchor recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling Healix Knotless ADV BR 4.75 Suture Anchor, distributed nationwide in the US. The recall was initiated on 4 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 222330 Batch/Lot: 5L45257 GTIN: 10886705023462

Quantity recalled299

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0665-2020
FDA event ID: 84237
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Norwood, MA
Classification: Class II
Status: Terminated
Recall initiated: 4 Nov 2019
FDA classified: 10 Dec 2019
Reported: 18 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

4 Nov 2019	Recall initiated by company
10 Dec 2019	Classified by FDA	+36 days
18 Dec 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Healix Knotless ADV BR 4.75 Suture Anchor

Where it was distributed

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

Nationwide Alabama Arizona California Connecticut Florida Iowa Illinois Louisiana Massachusetts Maryland Michigan Minnesota Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number: 222330 Batch/Lot: 5L45257 GTIN: 10886705023462

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84237

Reported	Class	Recall	Company	Reason	Where
18 Dec 2019	CLASS II	Healix Knotless ADV BR 5.5 Suture Anchor recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide

More recalls from DePuy Mitek, Inc., a Johnson & Johnson

All 51

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Device	CLASS II	COR Disposable Kit w/ Perpendicularity recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
19 Mar 2025Device	CLASS II	COR Disposable Kit Cartilage Transplant System recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide