medical MODERATE Updated 2026-03-18

International Life Sciences recalls Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HE

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Recalled Product

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

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Hazard / Issue

Augmentation devices failed bacterial endotoxin testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: RK29976/GTIN: 00850003396248

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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