Z-1538-2016Class II

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260...

Name: Z-1538-2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260...
Creator: Smith & Nephew, Inc.
Published: 2016-03-11
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-03-11 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product Usage: Tibial... on 2016-03-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1538-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Posted: 2016-04-21
Terminated: 2017-04-10
Recalling firm: Smith & Nephew, Inc.
Product: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: 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: [email protected]
Quantity in commerce: 6 units
Distribution: International Distribution only in countries of: Germany and Switzerland.
Product codes and lots: Batch number C1507158

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1538-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1537-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1538-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1539-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1540-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1541-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1542-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1543-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1544-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1545-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1546-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1547-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1548-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1549-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1550-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21
Z-1551-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-21

Product code JWH

K072858Class IITc-Plus Primary Knee SystemSmith & Nephew, Inc. / cleared 2007-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)