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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Spiked Washers 13.5/6.5

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  Class 2 Device Recall Synthes Spiked Washers 13.5/6.5 see related information
Date Initiated by Firm October 03, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on December 18, 2015
Recall Number Z-0394-2014
Recall Event ID 66580
510(K)Number K011583  
Product Classification Washer, bolt nut - Product Code HTN
Product Synthes Spiked Washers 13.5/6.5

Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Code Information part 219.951 with multiple lot#:   2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841 
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		 During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
FDA Determined
Cause 2		 Finished device change control
Action SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product located. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue, Monument, CO 80132 Customers were also asked to return the Verification Form indicating they did not have the affected product also. All documents were to be returned to Synthes by: Fax 1-877-270-5855 Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant For questions regarding this recall call 610-719-5000..
Quantity in Commerce 3087
Distribution Nationwide Distribution
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 = HTN and Original Applicant = SYNTHES (USA)
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