—#172638

Product

Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

FDA product code: MQV — Filler, Bone Void, Calcium Compound
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K043421
Affected lot / code info: UDI 10885862093202 Serial Numbers: T31634510, T31788559

Why it was recalled

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 (FDA determination)

Environmental control

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: OK, VA, FL

Timeline

Recall initiated: 2019-04-26
Terminated: 2021-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172638. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.