Reported Feb 5, 2014 · Terminated
The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to…
ACUTE Innovations, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ACUTE Innovations, LLC · 21421 NW Jacobson Rd Ste 700 · Hillsboro, OR · 97124-9311
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | 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 |
| 2 | RBL1302- 75 mm Rib Plate |
| 3 | RBL1303- 115 mm Rib Plate |
| 4 | RBL1304- 155 mm Rib Plate |
| 5 | RBL1305- 215 mm Rib Plate |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 RBL1301 for 50 mm Rib Plate: L1209002 2 L1302002 3 L1308001 4 RBL1302 for 75 mm Rib Plate: L1209003 5 L1302003 6 RBL1303 for 115 mm Rib Plate: L1209004 7 L1302004 8 RBL1304 for 155 mm Rib Plate: L1209005 9 RBL1305 for 215 mm Rib Plate: L1209006 - Amount recalled
- 176 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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