FDA DeviceClass IINotable

FDA Recall: Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Q

Name: FDA Recall: Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Q
Brand: International Life Sciences

Date: 2026-03-18

Brand: International Life Sciences

Category: Medical Device

FDA Class: Class II

Description

Augmentation devices failed bacterial endotoxin testing.

Hazard

Augmentation devices failed bacterial endotoxin testing.

Remedy

N/A

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