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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 Recall
Abbott Spine PathFinder, Cannulated Poly Screwdriver II MOD
see related information
Date Posted August 31, 2010
Recall Status1 Terminated on December 22, 2010
Recall Number Z-2335-2010
Recall Event ID 53811
Premarket Notification
510(K) Numbers
K030625  K071174 
Product Classification Orthosis, Spinal 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, Indiana 46580-2746
Consumer Instructions Contact the recalling firm for information
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/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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