WhichRecall
Class IIReported 2026-03-18

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

Recalled by International Life Sciences

Reason for Recall

Augmentation devices failed bacterial endotoxin testing.

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Recall Number
Z-1556-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-02-06
Reported
2026-03-18
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, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Code Info
Lot: RK29976/GTIN: 00850003396248
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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