Date Initiated by Firm | July 23, 2010 |
Create Date | June 26, 2015 |
Recall Status1 |
Terminated 3 on December 18, 2014 |
Recall Number | Z-2583-2010 |
Recall Event ID |
56343 |
510(K)Number | K053508 |
Product Classification |
Spinal vertebral body replacement device - Product Code MQP
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Product | SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure)
The implant holder is used to place the implant into the vertebral disc space. |
Code Information |
Catolog Number: 03.802.039 - all lot numbers |
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 | A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient. |
FDA Determined Cause 2 | Error in labeling |
Action | Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: FieldAction@Synthes.com.
If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant. |
Distribution | Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore. |
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 = MQP
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