| Class 2 Device Recall OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MRW
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