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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 2.4 and 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12 MM

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  Class 2 Device Recall Synthes 2.4 and 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12 MM see related information
Date Initiated by Firm July 31, 2013
Date Posted November 22, 2013
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-0380-2014
Recall Event ID 66411
510(K)Number K063049  
Product Classification Plate, fixation, bone - Product Code HRS
Product 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM
Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Code Information Lot 3420620
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		 Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.
FDA Determined
Cause 2		 Labeling mix-ups
Action Synthes sent an URGENT NOTICE: MEDICAL DEVICE RECALL letter dated July 31, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Nuber, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Fax the documents to Synthes at 1-866-792-6446 or email to 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 98
Distribution Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.
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 = HRS and Original Applicant = SYNTHES (USA)
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