Recall Z-1688-2019 ยท MQV Filler, Bone Void, Calcium Compound
Exactech, Inc.
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
| Date | Apr 26, 2019 |
| Status | Terminated |
| Reason | 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 | Environmental control |
| 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. |
| Quantity | 2 units |
| Distribution | OK, VA, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043421 | OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC Regeneration Technologies, Inc., Feb 16, 2005 |