CLASS II Device recall · Reported 27 Apr 2016 · FDA Enforcement Report
Tc-plus(TM), Primary Fixed Tibial Component Vks Left recalled
Smith & Nephew is recalling Tc-plus(TM), Primary Fixed Tibial Component Vks Left, Size 8 Left, Sterile R, distributed nationwide in the US. The recall was initiated on 11 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1538-2016
- FDA event ID
- 73609
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2016
- FDA classified
- 21 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 11 Mar 2016 | Recall initiated by company | |
| 21 Apr 2016 | Classified by FDA | +41 days |
| 27 Apr 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
International Distribution only in countries of: Germany and Switzerland.
Questions about this recall
Is Tc-plus(TM), Primary Fixed Tibial Component Vks Left, Size 8 Left, Sterile R recalled?
Yes. Smith & Nephew recalled Tc-plus(TM), Primary Fixed Tibial Component Vks Left, Size 8 Left, Sterile R on 11 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1538-2016.
Why was it recalled?
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.
Which lots are affected?
Batch number C1507158
Where was it sold?
International Distribution only in countries of: Germany and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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