HEALIX ADVANCE recallZ-0666-2020 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Nov 4, 2019

Why it was recalled

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.

FDA root cause category: Employee error

What the company is doing

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

Recall details

Recall number

Z-0666-2020

Status

Terminated

Initiated by the company

Nov 4, 2019

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Quantity

599

Product code

MAI

FDA submissions

K130917

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 description

Healix Knotless ADV BR 5.5 Suture Anchor

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• HEALIX ADVANCE 222331

  Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 recall196 reports

Product lines

• HEALIX ADVANCEDepuy Mitek, LLC · 6 models · 873 reports · 2 recalls

Other devices under the same FDA submission

1 device cleared under K130917 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• HEALIX ADVANCE 222330

  Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 recall607 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 84237).

• Z-0665-2020 · Terminated
  Healix Knotless ADV BR 4.75 Suture Anchor