FDA Device recall Z-0852-2014
The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fracture…
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fracture… by Acute Innovations, citing the ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0852-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-30 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Acute Innovations |
| Distribution | AZ, GA, IL, IN, UT, WI |
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.
Identifiers
| code_info | LOT numbers: RBL1301 for 50 mm Rib Plate: L1209002; L1302002; L1308001; RBL1302 for 75 mm Rib Plate: L120…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0852-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.