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Terminated

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

FDA Recall Z-1689-2019 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2019-04-26
Date Terminated2021-04-22
Product Quantity2 units

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.

Firm 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.

Root Cause

Environmental control

Distribution Pattern

OK, VA, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043421OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP ICRegeneration Technologies, Inc. · 2005-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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