Device recall

Z-1556-2026: Artelon FLEXBAND TWIST.12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX…

FDA device recall · Class II · International Life Sciences

Key facts

Recall number (Z-number) Z-1556-2026
Recall event 98399
Product Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Product code OWW
Recalling firm International Life Sciences
Recall class Class II
Status Open, Classified
510(k) numbers K200503, K230316
FEI number 3010673515

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)