FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: Healix Knotless ADV BR 5.5 Suture Anchor
- Recall number
- Z-0666-2020
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- Healix Knotless ADV BR 5.5 Suture Anchor
- Status
- Terminated
- Initiated
- 2019-11-04
- Posted
- not on file
- Terminated
- 2020-05-05
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479
- 510(k) numbers
- ["K130917"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 1221934
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28