Exactech, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1689-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 26, 2019

Date Posted: June 5, 2019

Recall Number: Z-1689-2019

Event ID: 82759

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.

Status: Terminated

Product Quantity: 2 units

Code Information:

UDI 10885862093219 Serial Numbers: T32309666, T32309672

Distribution Pattern:

OK, VA, FL

Voluntary or Mandated:

Voluntary: Firm initiated