Date Initiated by Firm | May 29, 2013 |
Date Posted | November 26, 2013 |
Recall Status1 |
Terminated 3 on May 21, 2015 |
Recall Number | Z-0401-2014 |
Recall Event ID |
66723 |
510(K)Number | K110354 |
Product Classification |
condylar plate fixation Implant - Product Code JDP
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Product | Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. |
Code Information |
part 04.124.406S, lot 3771678. |
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 | A plate was inadvertently released to a sales consultant that was restricted for sale. |
FDA Determined Cause 2 | Employee error |
Action | Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received. The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use. For questions the surgeon was instructed to call 800-620-7025.
For questions regarding this recall call 610-719-5000. |
Quantity in Commerce | 1 |
Distribution | US Distribution in Colorado. |
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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510(K) Database | 510(K)s with Product Code = JDP
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