Artelon FLEXBAND TWIST — Class II medical device recall Z-1556-2026
Ongoing recall by International Life Sciences, reported 2026-03-18, distributed nationwide. Augmentation devices failed bacterial endotoxin testing.
| Recall number | Z-1556-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Life Sciences, Atlanta, GA, United States |
| Recall initiated | 2026-02-06 |
| Classified | 2026-03-11 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CH, DE, ES, FR, GB, IT, JP, KR, SI |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00850003396248 |
| Lot numbers | RK29976 |
| Model numbers | 3.85X17MMHEX, TW012 |
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 for recall
Augmentation devices failed bacterial endotoxin testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1556-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.