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Recall Observatory FDA recall evidence

Device product

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,

Z-2634-2016

July 18, 2016

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 74850
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-2634-2016

Official wording

Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

Code information: P239049, P239142

Distribution pattern: AR, MN,MA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.