FDA recall Z-1689-2019

Product

Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45

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.

Distribution

OK, VA, FL

Key facts

Status

Terminated

Initiation date

2019-04-26

Report date

2019-06-05

Termination date

2021-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2019