Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1556-2026 — Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

U.S. FDA — Device Enforcement · United States · 2026-02-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1556-2026
Date of alert
2026-02-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
International Life Sciences
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850003396248
Reported risk: Augmentation devices failed bacterial endotoxin testing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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