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 proper insertion of the plates and screws. The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum. Part Numbers: RBL1301- 50 mm Rib Plate; RBL1302- 75 mm Rib Plate; RBL1303- 115 mm Rib Plate; RBL1304- 155 mm Rib Plate; RBL1305- 215 mm Rib Plate;
This recall has been terminated (originally issued January 28, 2014).
- Company
- Acute Innovations Llc
- Recall Initiated
- October 30, 2013
- Posted
- January 28, 2014
- Terminated
- March 13, 2014
- Recall Number
- Z-0852-2014
- Quantity
- 176 units
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
Reason for Recall
The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
Distribution
US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
Lot / Code Info
LOT numbers: RBL1301 for 50 mm Rib Plate: L1209002; L1302002; L1308001; RBL1302 for 75 mm Rib Plate: L1209003; L1302003; RBL1303 for 115 mm Rib Plate: L1209004; L1302004; RBL1304 for 155 mm Rib Plate: L1209005; RBL1305 for 215 mm Rib Plate: L1209006;
Root Cause
Under Investigation by firm
Action Taken
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.