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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Synthes Titanium Recon Screws

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  Class 2 Device Recall DePuy Synthes Titanium Recon Screws see related information
Date Initiated by Firm May 27, 2015
Date Posted June 26, 2015
Recall Status1 Terminated 3 on December 18, 2015
Recall Number Z-1915-2015
Recall Event ID 71361
510(K)Number K040336  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
Code Information Part Numbers :  04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031  with Lot Numbers:  8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036 
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).
FDA Determined
Cause 2		 Process control
Action DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: ¿ Review the information listed in this notification. ¿ Forward this notice to anyone in your facility that needs to be informed. ¿ Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by: ¿ Fax: (888) 912-2182 or ¿ Scan/email: Synthes4844@stericycle.com ¿ If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. ¿ Maintain a copy of this notice. If you have any questions, please call (610)719-5450. Thank you for your attention to this issue.
Quantity in Commerce 276
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 = HSB and Original Applicant = SYNTHES (USA)
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