Recall Z-0336-2012 ยท HRS Plate, Fixation, Bone
Acute Innovations Llc
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
| Date | Dec 1, 2011 (initiated Feb 28, 2011) |
| Status | Terminated |
| Reason | RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 299 units (267 in US and 32 to South Africa) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051410 | ACUMED RIB CONGRIENT BONE PLATE SYSTEM Acumed, LLC, Jul 21, 2005 |