Recall Z-0212-2020— CrossRoads Extremity Systems, LLC

Name: FDA recall Z-0212-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-19

Class II · Terminated

Class II FDA medical device recall by CrossRoads Extremity Systems, LLC, initiated 2019-09-19, terminated 2021-12-02. It names one FDA 510(k) clearance: K173710. Product: MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm. Reason: Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw..

Recalling firm: CrossRoads Extremity Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-09-19
Terminated: 2021-12-02
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K173710 — MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC·cleared 2018-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.