Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number… recallZ-1688-2019 · Exactech, Inc. · initiated Apr 26, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Environmental control
What the company is doing
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.
Recall details
- Recall number
- Z-1688-2019
- Status
- Terminated
- Initiated by the company
- Apr 26, 2019
- Recalling firm
- Exactech, Inc.
- Quantity
- 2 units
- Product code
- MQV
- FDA submissions
- K043421
- Distribution
- OK, VA, FL
Product description
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Code information (models, lots, serial numbers)
UDI 10885862093202 Serial Numbers: T31634510, T31788559
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OPTEFORM® Allograft Disc, 30mm x 3mm, 2cc 002530Rti Surgical, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K043421 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc 002545Rti Surgical, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
- OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc 002590Rti Surgical, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 82759).
- Z-1689-2019 · TerminatedOpteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
- Z-1690-2019 · TerminatedOpteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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