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Recall Observatory FDA recall evidence

Device product

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

Z-1556-2026

February 06, 2026

Class II

Product summary

Firm
International Life Sciences
Event
Event 98399
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1556-2026

Official wording

Reason: Augmentation devices failed bacterial endotoxin testing.

Code information: Lot: RK29976/GTIN: 00850003396248

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Augmentation devices failed bacterial endotoxin testing.