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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Slipped Capital Femoral Epiphysis System

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  Class 2 Device Recall Synthes Slipped Capital Femoral Epiphysis System see related information
Date Initiated by Firm July 31, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on June 01, 2015
Recall Number Z-0408-2014
Recall Event ID 66412
Product Classification Bit, drill - Product Code HTW
Product Slipped Capital Femoral Epiphysis System

Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Code Information Parts 03.207.001 and 03.207.008 with lot numbers:   Part # Lot # 03.207.001 PE00376  PE00439  PE01391  PE01329  PE01412  PE00504 03.207.008 PE00440  PE00377  PE00513  PE01475  PE01691 
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		 There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
FDA Determined
Cause 2		 Device Design
Action Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
Quantity in Commerce 166
Distribution USA 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.
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