DePuy Mitek Recalls Healix Knotless Suture Anchors Due to Material Error
DePuy Mitek is recalling 599 Healix Knotless Suture Anchors because they were manufactured with BIOCRYL material instead of BIOCRYL RAPIDE.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 voluntary precautionary recall.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson company, is recalling 599 units of the Healix Knotless ADV BR 5.5 Suture Anchor. The recall is due to a manufacturing error where specific product codes and lots were produced using BIOCRYL Biocomposite Material instead of the intended BIOCRYL RAPIDE Biocomposite Material.
The source text notes that both BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation. The affected 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.
Healthcare providers and patients should check their inventory and patient records for the specific part number 222331 and batch/lot numbers 5L45259 or 5L13543. If these specific units are identified, they should be removed from use and returned to DePuy Mitek in accordance with the recall instructions.
The recalled product
- Product
- Healix Knotless ADV BR 5.5 Suture Anchor
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 599
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 (2)
- Part Number: 222331 Batch/Lot: 5L45259
- 5L13543 GTIN: 10886705023479
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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