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U.S. Department of Health and Human Services

Class 3 Device Recall STANDARD RING

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  Class 3 Device Recall STANDARD RING see related information
Date Initiated by Firm September 21, 2020
Create Date November 05, 2020
Recall Status1 Terminated 3 on December 30, 2022
Recall Number Z-0416-2021
Recall Event ID 86545
510(K)Number K983766  K003275  
Product Classification Spinal vertebral body replacement device - Product Code MQP
Product STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
Code Information Lot Numbers: 19P7847 20P1747 21P3268 H865134
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall		 Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Synthes GMBH is reporting Recall of SYNMESH CAGE SYSTEM Japan-Specific Country Label Issue . The Japan affiliate will be administering the recall per their local regulations, the week of September 21, 2020. Affiliate will notify Japanese sales representatives. Japanese sales representatives will hand-deliver notices to affected hospitals / surgeons. The Japan affiliate is responsible for managing the rework process. Returned devices will be reworked with correct Japan-specific labels and revised lots
Quantity in Commerce 6 units
Distribution International distribution the country of Japan Only.
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 = MQP and Original Applicant = SYNTHES (USA)
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