Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Reported: June 5, 2019 Initiated: April 26, 2019 #Z-1689-2019
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.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 2 units
- Distribution
- OK, VA, FL
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45. Recalled by Exactech, Inc.. Units affected: 2 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2019. Severity: Moderate. Recall number: Z-1689-2019.
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