International Life Sciences: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Recall Summary International Life Sciences is recalling Artelon FLEXBAND TWIST surgical mesh kits used in orthopedic tendon reinforcement procedures because the augmentation devices failed bacterial endotoxin testing. The recall affects products distributed nationwide across the United States and in multiple countries including Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, and the United Kingdom. This is classified as a Class II recall.
- Recalling firm
- International Life Sciences
- Product
- Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
- Reason
- Augmentation devices failed bacterial endotoxin testing.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/36cd5b8c-e7e4-4a54-a6a3-efa1ea309a64