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Class 2 Device Recall Abbott Spine PathFinder, Cannulated Poly Screwdriver II MOD |
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Date Initiated by Firm |
January 12, 2009 |
Date Posted |
August 31, 2010 |
Recall Status1 |
Terminated 3 on December 22, 2010 |
Recall Number |
Z-2335-2010 |
Recall Event ID |
53811 |
510(K)Number |
K030625 K071174
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Product Classification |
Orthosis, spina pedicle fixation - Product Code MNI
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Product |
Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2.
Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting. |
Code Information |
All units. Lots 36WC, 39BA, 43MN, 44WP, 47FE, 18TH, 20XF, 25WE, 29CQ, 29YJ, 31TJ, 33ZH, 47RM, 48PC, 49QW, 51PF and 58SD. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact |
S. Dale Miller 574-267-6131
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Manufacturer Reason for Recall |
The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
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FDA Determined Cause 2 |
Other |
Action |
The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice.
For questions or assistance, please contact Zimmer Spine at 800-326-0635. |
Quantity in Commerce |
691 |
Distribution |
Worldwide. |
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 = MNI and Original Applicant = ABBOTT SPINE, INC. 510(K)s with Product Code = MNI and Original Applicant = SPINAL CONCEPTS, INC.
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