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Recall Observatory FDA recall evidence

Device product

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1547-2016

March 11, 2016

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 73609
Status
Terminated
Classification
Class II
Quantity
33 units
Official record key
device-enforcement:Z-1547-2016

Official wording

Reason: 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.

Code information: Batch numbers: B1512224, B1509601, B1506853, B1501435, B1500308

Distribution pattern: International Distribution only in countries of: Germany and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.