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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic Template

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  Class 2 Device Recall Orthopedic Template see related information
Date Initiated by Firm August 10, 2017
Date Posted February 12, 2018
Recall Status1 Terminated 3 on August 08, 2018
Recall Number Z-0591-2018
Recall Event ID 79042
Product Classification Template - Product Code HWT
Product NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468)

The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
Code Information The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946
Manufacturer Reason
for Recall		 The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On August 21, 2017 an Urgent Medical Device Recall notification was issued titled "NS357R Tibia Trial Plateau" asking distributors to inspect Sets #0468 and follow the inspection instructions on the customer notification letter and immediately remove the affected part and return to Aesculap Implant Systems. Questions or concerns can be directed to Customer Service at 314-551-5998
Quantity in Commerce 13 Units
Distribution USA (nationwide)
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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