Class 2 Device Recall MotoBand CP, Polyaxial Locking Screw

• Date Initiated by Firm: September 19, 2019
• Create Date: October 24, 2019
• Recall Status: Terminated on December 02, 2021
• Recall Number: Z-0212-2020
• Recall Event ID: 83934
• 510(K)Number: K173710
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
• Code Information: Part Number: 15PL-3028, Lot Number: 500750
• FEI Number: 3020584246
• Recalling Firm/ Manufacturer: CrossRoads Extremity Systems, LLC; 6055 Primacy Pkwy Ste 140; Memphis TN 38119-5702
• For Additional Information Contact: Kim Strohkirch; 901-221-8406
• Manufacturer Reason for Recall: Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.
• FDA Determined Cause: Labeling mix-ups
• Action: 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.
• Quantity in Commerce: 36 screws
• Distribution: Nationwide distribution to AK, CA, FL, GA, IL, MA, MN, NC, NJ, OK, OR, WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HWC