medical Class II Updated 2019-12-18

DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Healix Knotless ADV BR 5.5 Suture Anchor

Recalled Product

Healix Knotless ADV BR 5.5 Suture Anchor

Hazard / Issue

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.

Issued by

FDA

Affected States: 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
Lot/Code Info: Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479
View official government recall

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