Opteform Allograft Disc — Class II medical device recall Z-1688-2019
Terminated recall by Exactech, Inc., reported 2019-06-05, distributed in FL, OK, VA. The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperat
| Recall number | Z-1688-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2019-04-26 |
| Classified | 2019-05-29 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2021-04-22 |
| Distributed | FL, OK, VA |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 10885862093202 |
| Serial numbers | T31634510, T31788559 |
| Model numbers | 600-03-30 |
Product
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Reason for recall
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
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-1688-2019. 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.