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U.S. Department of Health and Human Services

Class 2 Device Recall OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft

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  Class 2 Device Recall OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft see related information
Date Initiated by Firm June 07, 2011
Date Posted October 04, 2011
Recall Status1 Terminated 3 on December 04, 2012
Recall Number Z-0008-2012
Recall Event ID 59213
510(K)Number K102438  
Product Classification System, facet screw spinal device - Product Code MRW
Product OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Code Information Part Number 800-1212 lot # 1038452.
Recalling Firm/
Manufacturer		 Osteomed, Lp
3885 Arapaho Rd
Addison TX 75001
For Additional Information Contact Rebecca L. Ellis
800-456-7779
Manufacturer Reason
for Recall		 Two of the Implant Driver Assembly tips were reported to break during surgery.
FDA Determined
Cause 2		 Device Design
Action OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address. Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.
Quantity in Commerce 20 units
Distribution Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO
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 = MRW and Original Applicant = OSTEOMED L.P.
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