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Artelon FlexBand Dynamic Matrix
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MEDICAL DEVICE RECALLMODERATE

Artelon FlexBand Dynamic Matrix

Artelon FlexBand Dynamic Matrix recalled over failed endotoxin testing.

What to do

Stop using the affected Artelon FlexBand Dynamic Matrix devices and contact International Life Sciences for instructions on returning the product and obtaining a replacement or refund.

Recalled
Listed
Updated
Recall No.
Z-1554-2026
Agency
FDA
Firm
International Life Sciences
Recall ID
98399
Status
ONGOING

Why it was recalled

International Life Sciences is recalling Artelon FlexBand Dynamic Matrix augmentation devices because they failed bacterial endotoxin testing, posing a risk of infection or inflammatory response in patients.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
Artelon FlexBand Dynamic Matrix Ref: 31057Z-1554-202600850003396019
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)Z-1556-202600850003396248
Artelon FlexBand Plus Ref: 41054 & 41057Z-1555-202600850003396064, 00850003396033

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification