10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE" The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.
This recall has been terminated (originally issued December 1, 2011).
- Company
- Acute Innovations Llc
- Recall Initiated
- February 28, 2011
- Posted
- December 1, 2011
- Terminated
- December 6, 2011
- Recall Number
- Z-0336-2012
- Quantity
- 299 units (267 in US and 32 to South Africa)
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
Reason for Recall
RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.
Distribution
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, GA, IL, MN, NC, NY, UT, and WA; and countries of: South Africa.
Lot / Code Info
lot L1008007; Part # RBP1202
Root Cause
Process control
Action Taken
The firm, ACUTE Innovation, sent an "URGENT NOTICE: DEVICE RECALL" letter dated February 21, 2011, to all consignees/customers via FED-EX on February 28, 2011. The letter describes the product, problem and actions to be taken. The customers were instructed to identify product having the lot code(s) and quarantine them; return all product from this lot to Acute Innovations immediately using shipping labels provided or return to: Acute Innovations, LLC, 21421 NW Jacobson Rd, Suite 700, Hillsboro, OR, 97124, and if they further distributed this product, notify those customers of this recall and request return of product(s). Customers can call ACUTE Innovation at 1-866-623-4137 for any questions about this recall.