Medtronic Sofamor Danek USA Inc: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

Agency Publication Date: August 23, 2016

Affected Products

Product: RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,

P239050

Product: RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,

P239150

Product: RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,

P239157

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

P239049, P239142

Product: TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

P239166, P239167,

Product: TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement

P236112, P239165

Product: TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

P239168, P239169

Product: TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

P239175

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74850

Status: Resolved

Manufacturer: Medtronic Sofamor Danek USA Inc

Manufactured In: United States

Units Affected: 7 products (3 units; 3; 4 units; 3 units; 3 units; 2 units; 1 unit)

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Sources: FDA iRES · Raw API Response

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