Integra bioBLOCK Resorbable subtaler Implant — Class II medical device recall Z-1091-2019
Terminated recall by Integra Limited, reported 2019-04-17, distributed nationwide. Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indi
| Recall number | Z-1091-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra Limited, Plainsboro, NJ, United States |
| Recall initiated | 2019-03-01 |
| Classified | 2019-04-05 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-06-22 |
| Distributed | Nationwide (US) |
| Quantity | 232 total |
| Lot numbers | FGD8329 |
| Model numbers | 040012 |
Product
Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Reason for recall
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
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-1091-2019. 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.