Opteform Allograft Disc recall
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Why was Opteform Allograft Disc 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 10885862093219 Serial Numbers: T32309666, T32309672
- Product
- Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
- Recalling firm
- Exactech, Inc.
- Quantity
- 2 units
- Distribution
- OK, VA, FL
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)