Z-0666-2020Class II

Healix Knotless ADV BR 5.5 Suture Anchor

Name: Z-0666-2020 Healix Knotless ADV BR 5.5 Suture Anchor
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2019-11-04
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2019-11-04 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Healix Knotless ADV BR 5.5 Suture Anchor on 2019-11-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0666-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Posted: 2019-12-10
Terminated: 2020-05-05
Recalling firm: DePuy Mitek, Inc.
Product: Healix Knotless ADV BR 5.5 Suture Anchor
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On November 4, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail: URGENT FIELD SAFETY NOTICE PRODUCT RECALL HEALIX ADVANCE" Knotless Anchors Dear Valued Customer, On 04-November-2019, DePuy Mitek, Inc. initiated a Voluntary Product Removal of specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors. The 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. No complaints or adverse events related to this issue have been received for the affected product codes/lots. Product Code: 222330 Product Description: HEALIX KNOTLESS ADV BR 4.75 GTIN: 10886705023462 Lot Number: 5L45257 Product Code: 222331 Product Description: HEALIX KNOTLESS ADV BR 5.5 GTIN: 10886705023479 Lot Numbers: 5L13543 and 5L45259 Potential Harms: Based on the analysis, it is expected that sport medicine implants made from BIOCRYL (PLLA+TCP) would perform equal to those made from BIOCRYL RAPIDE (PLGA + TCP) during the surgery and therapeutic healing period. As such, this product issue presents no foreseeable increased risk to patient safety nor does it alter the product benefit-risk profile. BIOCRYL and BIOCRYL RAPIDE Comparison: " Each material is used clinically today, but in different DePuy Mitek implant brands; both materials have a more than 15 years of use in clinical applications. BIOCRYL was first launched in 2002 and BIOCRYL RAPIDE in 2004. " The mechanical properties (strength, stiffness) of BIOCRYL and BIOCRYL RAPIDE are similar at the time of anchor deployment; BIOCRYL offers equivalent in vitro strength retention during the therapeutic healing period and out to 12 weeks. " As for long-term absorption rates, BIOCRYL RAPIDE is expected to absorb in approximately two years versus approximately four years
Quantity in commerce: 599
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
Product codes and lots: Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0666-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0665-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-10
Z-0666-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-10

Product code MAI

K130917Class IIHealix Advance Knotless Br AnchorDepuy Mitek, A Johnson & Johnson Company / cleared 2013-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)