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U.S. Department of Health and Human Services

Class 2 Device Recall RibLoc System, Standard Screw

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  Class 2 Device Recall RibLoc System, Standard Screw see related information
Date Initiated by Firm February 28, 2011
Date Posted December 01, 2011
Recall Status1 Terminated 3 on December 06, 2011
Recall Number Z-0336-2012
Recall Event ID 60286
510(K)Number K051410  
Product Classification Plate, fixation, bone - Product Code HRS
Product 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.
Code Information lot L1008007; Part # RBP1202
Recalling Firm/
Manufacturer		 Acute Innovations Llc
21421 Nw Jacobson Rd Ste 700
Hillsboro OR 97124-9311
For Additional Information Contact Mariah [NMI] Knight
503-686-7200
Manufacturer Reason
for Recall		 RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.
FDA Determined
Cause 2		 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 request return of product(s). Customers can call ACUTE Innovation at 1-866-623-4137 for any questions about this recall.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ACUMED LLC
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