Exact FDA event identifier

Event 84237

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: November 04, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: DePuy Mitek, Inc., a Johnson & Johnson Co.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Healix Knotless ADV BR 4.75 Suture Anchor

Z-0665-2020

Recall number: Z-0665-2020
Initiated: November 04, 2019
Classification: Class II
Status: Terminated
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity: 299

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 2 of 2

Healix Knotless ADV BR 5.5 Suture Anchor

Z-0666-2020

Recall number: Z-0666-2020
Initiated: November 04, 2019
Classification: Class II
Status: Terminated
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity: 599

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479