Recall Z-0852-2014 ยท HRS Plate, Fixation, Bone
ACUTE Innovations, LLC
The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufactured from titanium alloy. Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the pro
| Date | Jan 28, 2014 (initiated Oct 30, 2013) |
| Status | Terminated |
| Reason | The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery. |
| Root cause | Under Investigation by firm |
| Action | The firm sent the Urgent Notice: Device Recall letter, dated 30 Oct. 2013, to their consignees. The recall notification letter requested consignees to return the product to Acute and a return authorization number provided. Consignees should contact Acute Innovations Customer Service at 866-623-4137 for any questions regarding this recall notification. |
| Quantity | 176 units |
| Distribution | US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113318 | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM Acute Innovations, LLC, Jan 12, 2012 |