FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
- Recall number
- Z-1689-2019
- Recalling firm
- Exactech, Inc.
- Product
- Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
- Status
- Terminated
- Initiated
- 2019-04-26
- Posted
- not on file
- Terminated
- 2021-04-22
- 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.
- Root cause
- Environmental control
- Action
- The firm initiated the recall on 04/26/2019 by electronic mail. The notice requested the consignee cease distribution of the product, notify their customers (the user), quarantine all units subject to recall in inventory, and if any units were implanted to follow-up on the patient's condition 30 days after surgery.
- Quantity
- 2 units
- Distribution
- OK, VA, FL
- Lot, serial or model codes
- UDI 10885862093219 Serial Numbers: T32309666, T32309672
- 510(k) numbers
- ["K043421"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28