DePuy Mitek Recalls Healix Knotless Suture Anchors Due to Material Error
DePuy Mitek is recalling 299 Healix Knotless ADV BR 4.75 Suture Anchors because they were manufactured with BIOCRYL material instead of BIOCRYL RAPIDE.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that both materials are biocompatible and effective, and no injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 299 units of the Healix Knotless ADV BR 4.75 Suture Anchor. The recall is identified by FDA recall number Z-0665-2020 and is classified as a Class II recall.
The affected products were manufactured with BIOCRYL Biocomposite Material instead of the intended BIOCRYL RAPIDE Biocomposite Material. According to the source text, both BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
The affected units are identified by Part Number 222330, Batch/Lot 5L45257, and GTIN 10886705023462. These products were distributed in the United States and internationally to Belgium, Chile, China, Czech Republic, France, India, Japan, Korea, Latvia, New Zealand, Slovakia, and Sweden.
The recalled product
- Product
- Healix Knotless ADV BR 4.75 Suture Anchor
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 299
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: 222330 Batch/Lot: 5L45257 GTIN: 10886705023462
Distribution
Part of a larger recall action
This product is one of 2 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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