Class 2 Device Recall MotoCLIP(TM) Super Elastic Fusion System

• Date Initiated by Firm: February 16, 2017
• Date Posted: March 20, 2017
• Recall Status: Terminated on April 27, 2017
• Recall Number: Z-1487-2017
• Recall Event ID: 76687
• 510(K)Number: K142727
• Product Classification: Staple, fixation, bone - Product Code JDR
• Product: MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
• Code Information: Lot Number 101868
• Recalling Firm/ Manufacturer: Crossroads Extremity Systems Llc; 6055 Primacy Pkwy Ste 140; Memphis TN 38119-5702
• For Additional Information Contact: Vernon Hartdegen ; 901-221-8406 Ext. 102
• Manufacturer Reason for Recall: Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
• FDA Determined Cause: Labeling mix-ups
• Action: The firm notified their distributors by email on 02/16-17/2017. The distributors were asked to return the unused lot #101866. The firm also contacted the implanting surgeons either by visit or telephone about the potential for an incorrect size of the implant and asked if there were any adverse events.
• Quantity in Commerce: 20 units
• Distribution: Al, FL, IN, Il, NE, TX, NM, CO, AZ
• 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 = JDR