TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephe

FDA device recall Z-1545-2016 · posted 2016-04-21 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc.

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.

Action taken

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

Root cause

Process control

Status

Terminated

Product code

JWH

Quantity affected

22 units

Distribution

International Distribution only in countries of: Germany and Switzerland.

Date initiated

2016-03-11

Date posted

2016-04-21

Date terminated

2017-04-10

Location

Memphis, TN

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