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;
FDA Recall Z-0852-2014 · Posted 2014-01-28
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Recalling FirmACUTE Innovations, LLC
Recall StatusTerminated
Product CodeHRS
Date Initiated2013-10-30
Date Terminated2014-03-13
Product Quantity176 units
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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