Z-0852-2014Class II

The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are...

Name: Z-0852-2014 The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are...
Creator: ACUTE Innovations, LLC
Published: 2013-10-30
License: https://open.fda.gov/license/

Acute Innovations, LLC / initiated 2013-10-30 / Terminated

FDA source

ACUTE Innovations, LLC began a recall of The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and... on 2013-10-30. FDA classified it as Class II and gives the reason as "The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0852-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-30
Posted: 2014-01-28
Terminated: 2014-03-13
Recalling firm: Acute Innovations, LLC
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;
Product code: HRS Plate, Fixation, Bone
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 root cause: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0852-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0852-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code HRS

K113318Class IIAcute Innovations Modular Ribloc SystemAcute Innovations, LLC / cleared 2012-01-12

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)