| Class 2 Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS | |
Date Initiated by Firm | March 11, 2016 |
Date Posted | April 21, 2016 |
Recall Status1 |
Terminated 3 on April 10, 2017 |
Recall Number | Z-1541-2016 |
Recall Event ID |
73609 |
510(K)Number | K072858 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis |
Code Information |
Batch number C1507159 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact | Joe Metzger 978-749-1330 |
Manufacturer Reason for Recall | The Affected Devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base
plate during surgery. |
FDA Determined Cause 2 | Process control |
Action | The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com |
Quantity in Commerce | 4 units |
Distribution | International Distribution only in countries of: Germany and Switzerland. |
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 = JWH
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