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U.S. Department of Health and Human Services

Class 2 Device Recall The Spetzler Claw"

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  Class 2 Device Recall The Spetzler Claw" see related information
Date Initiated by Firm March 22, 2016
Date Posted April 13, 2016
Recall Status1 Terminated 3 on July 19, 2016
Recall Number Z-1378-2016
Recall Event ID 73610
510(K)Number K020220  
Product Classification Instrument, ultrasonic surgical - Product Code LFL
Product Spetzler Claw Tip, Universal - 5450-800-311
Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313

The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.
Code Information 5450-800-311  Lot Number 0545410 5450-800-313  Lot Number 0555170
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kara Spath
269-389-4518
Manufacturer Reason
for Recall		 The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On 3/22/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Kara Spath 269-389-4518 kara.spath@stryker.com
Quantity in Commerce 140 units
Distribution Distributed in the states of AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA, and in the NETHERLANDS.
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 = LFL and Original Applicant = SYNERGETICS, INC.
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