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U.S. Department of Health and Human Services

Class 2 Device Recall ACUTE Innovations Ribloc U plus Rib Fracture Plating System

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  Class 2 Device Recall ACUTE Innovations Ribloc U plus Rib Fracture Plating System see related information
Date Initiated by Firm October 30, 2013
Date Posted January 28, 2014
Recall Status1 Terminated 3 on March 13, 2014
Recall Number Z-0852-2014
Recall Event ID 67117
510(K)Number K113318  
Product Classification Plate, fixation, bone - Product Code HRS
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;


Code Information 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; 
Recalling Firm/
Manufacturer		 ACUTE Innovations, LLC
21421 NW Jacobson Rd Ste 700
Hillsboro OR 97124-9311
For Additional Information Contact Customer Service
866-623-4137
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 176 units
Distribution US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ACUTE INNOVATIONS LLC
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