Home / Recalls / DePuy Mitek, Inc., a Johnson & Johnson Co. / Z-0666-2020

Z-0666-2020 Class II Terminated

Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. — Norwood, MA

Recall Details

Product Type
Devices
Report Date
December 18, 2019
Initiation Date
November 4, 2019
Termination Date
May 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
599

Product Description

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.

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

Code Information

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

Other recalls by DePuy Mitek, Inc., a Johnson & Johnson Co.

  • Z-1315-2025 Class II — COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. (February 24, 2025)
  • Z-1314-2025 Class II — COR Disposable Kit, 8 mm. Cartilage Transplant System. (February 24, 2025)
  • Z-1678-2023 Class II — DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bon (April 13, 2023)
  • Z-1677-2023 Class II — DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bo (April 13, 2023)
  • Z-1679-2023 Class II — DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixa (April 13, 2023)
  • Z-1680-2023 Class II — DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fix (April 13, 2023)
  • Z-1681-2023 Class II — DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fi (April 13, 2023)
  • Z-0665-2020 Class II — Healix Knotless ADV BR 4.75 Suture Anchor (November 4, 2019)
  • Z-0208-2019 Class II — Mitek Screw and Washer Depth Gauge, Product Code 219024 (August 30, 2018)
  • Z-1749-2018 Class II — LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERI (December 22, 2017)