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U.S. Department of Health and Human Services

Class 2 Device Recall OctaneC Cervical, 6 Lordotic

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  Class 2 Device Recall OctaneC Cervical, 6 Lordotic see related information
Date Initiated by Firm June 15, 2012
Date Posted July 31, 2012
Recall Status1 Terminated 3 on July 03, 2013
Recall Number Z-2120-2012
Recall Event ID 62566
510(K)Number K103655  
Product Classification Intervertebral fusion device with bone graft, cervical - Product Code ODP
Product Octane-C Cervical, 6¿ Lordotic
Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Code Information Sizes:  5 mm Catalog # 05-010-02-0605 All serial numbers 6 mm Catalog # 05-010-02-0606 All serial numbers 7 mm Catalog # 05-010-02-0607 All serial numbers 8 mm Catalog # 05-010-02-0608 All serial numbers 9 mm Catalog # 05-010-02-0609 All serial numbers 10mm Catalog # 05-010-02-0610 All serial numbers 11mm Catalog # 05-010-02-0611 All serial numbers 12mm Catalog # 05-010-02-0612 All serial numbers 
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Graham L. Cuthbert
352-377-1140
Manufacturer Reason
for Recall		 Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
FDA Determined
Cause 2		 Labeling False and Misleading
Action Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832. For questions regarding this recall call 352-377-1140.
Quantity in Commerce 54,877 units for all products in Recall Event
Distribution Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
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 = ODP and Original Applicant = EXACTECH, INC.
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