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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Spine PathFinder, Cannulated Poly Screwdriver II MOD

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  Class 2 Device Recall Abbott Spine PathFinder, Cannulated Poly Screwdriver II MOD see related information
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  
Product Classification Orthosis, spina pedicle fixation - Product Code MNI
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
For Additional Information Contact S. Dale Miller
574-267-6131
Manufacturer Reason
for Recall		 The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
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
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 = MNI and Original Applicant = ABBOTT SPINE, INC.
510(K)s with Product Code = MNI and Original Applicant = SPINAL CONCEPTS, INC.
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