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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall MotoCLIP(TM) Super Elastic Fusion System see related information
Date Initiated by Firm February 16, 2017
Date Posted March 20, 2017
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems
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