Recall Z-0852-2014— ACUTE Innovations, LLC

Name: FDA recall Z-0852-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-30

Class II · Terminated

Class II FDA medical device recall by ACUTE Innovations, LLC, initiated 2013-10-30, terminated 2014-03-13. It names one FDA 510(k) clearance: K113318. Product: 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;. 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..

Recalling firm: ACUTE Innovations, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-10-30
Terminated: 2014-03-13
Firm location: Hillsboro, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K113318 — ACUTE INNOVATIONS MODULAR RIBLOC SYSTEMAcute Innovations, LLC·cleared 2012-01-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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;

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.