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
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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 |
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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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