The ACUTE Innovations Modular RibLoc System — Class II medical device recall Z-0852-2014
Terminated recall by ACUTE Innovations, LLC, reported 2014-02-05, distributed in AZ, GA, IL, IN, UT, WI. The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to ma
| Recall number | Z-0852-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACUTE Innovations, LLC, Hillsboro, OR, United States |
| Recall initiated | 2013-10-30 |
| Classified | 2014-01-28 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2014-03-13 |
| Distributed | AZ, GA, IL, IN, UT, WI |
| Quantity | 176 units |
| Reason classes | device malfunction |
| Lot numbers | RBL1301 |
| Model numbers | RBL1301 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0852-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.