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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Spiral Blade Component of the Synthes Modular Blade Plate System

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  Class 2 Device Recall Synthes Spiral Blade Component of the Synthes Modular Blade Plate System see related information
Date Initiated by Firm October 27, 2010
Date Posted February 16, 2011
Recall Status1 Terminated 3 on April 16, 2015
Recall Number Z-1299-2011
Recall Event ID 57318
510(K)Number K080109  
Product Classification Appliance, fixation, nail/blade/plate combination - Product Code KTW
Product 02.122.600, 100mm Spiral Blade, 14mm,
Right- Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Code Information All lots of Part Number: 02.122.600, 100mm Spiral Blade, 14mm, Right
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Potential for out of specification star grind teeth.
FDA Determined
Cause 2		 Other
Action Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time. Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the recalled product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. For questions regarding this recall call 1-800-620-7025, x 6883.
Quantity in Commerce 15
Distribution Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.
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 = KTW and Original Applicant = SYNTHES (USA)
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