Recall Z-1689-2019— Exactech, Inc.

Name: FDA recall Z-1689-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-26

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2019-04-26, terminated 2021-04-22. It names one FDA 510(k) clearance: K043421. 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..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-04-26
Terminated: 2021-04-22
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K043421 — OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP ICRegeneration Technologies, Inc.·cleared 2005-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.