FDA Device 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)
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) by International Life Sciences, citing augmentation devices failed bacterial endotoxin testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1556-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-06 |
| Published | 2026-03-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | International Life Sciences |
| Distribution | US |
Product
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Reason
Augmentation devices failed bacterial endotoxin testing.
Identifiers
| code_info | Lot: RK29976/GTIN: 00850003396248 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1556-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.