CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report
Modular RibLoc System (RibLoc U plus) is comprised titanium recalled
ACUTE Innovations is recalling The Acute Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates, distributed in Arizona, Georgia, Illinois, Indiana, Utah, Wisconsin. The recall was initiated on 30 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0852-2014
- FDA event ID
- 67117
- Recalling firm
- ACUTE Innovations, Hillsboro, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Oct 2013
- FDA classified
- 28 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 30 Oct 2013 | Recall initiated by company | |
| 28 Jan 2014 | Classified by FDA | +90 days |
| 5 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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;
Where it was distributed
US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
Questions about this recall
Is Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are recalled?
Yes. ACUTE Innovations recalled Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are on 30 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0852-2014.
Why was it recalled?
The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
Which lots are affected?
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;
Where was it sold?
US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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