FDA Device

MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm

Hazard

Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.

What You Should Do

Remedy

CrossRoads Extremity Systems notified customers on about 09/19/2019 via email. The email informed customers that pack-out potentially includes a 3.0mm x 30mm screw instead of 3.0 x 28mm screw. Instructions included to return all affected screws to CrossRoads Extremity Solutions immediately with provided label and return materials authorization.

Products

MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
Brand
CrossRoads Extremity Systems, LLC
UPC
Part Number: 15PL-3028, Lot Number: 500750

Units Affected

36 screws