Date Initiated by Firm | January 01, 2009 |
Date Posted | October 08, 2010 |
Recall Status1 |
Terminated 3 on January 05, 2011 |
Recall Number | Z-0032-2011 |
Recall Event ID |
54527 |
510(K)Number | K002082 |
Product Classification |
Spinal Interlaminal Fixation Appliance - Product Code KWP
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Product | SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L |
Code Information |
10ZG, 12LY, 13XB, 15DZ, 30HP, 36FA, 40EG, 45XB, 7EB. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | 574-267-6131 |
Manufacturer Reason for Recall | The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events. |
FDA Determined Cause 2 | Other |
Action | The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force. |
Quantity in Commerce | 23,205 Units for ALL PRODUCTS IN THIS RECALL |
Distribution | The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution. |
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 = KWP
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