FDA Device recall Z-1689-2019
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
- FDA Device
- Class II
- terminated
- Published 2019-06-05
On 2019-06-05 the FDA classified a Class II recall of Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45 by Exactech, citing 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 st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1689-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-26 |
| Published | 2019-06-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Exactech |
| Distribution | FL, OK, VA |
Product
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Reason
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.
Identifiers
| code_info | UDI 10885862093219 Serial Numbers: T32309666, T32309672 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1689-2019%22
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