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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 Systemsee related information
Date Initiated by FirmFebruary 16, 2017
Date PostedMarch 20, 2017
Recall Status1 Terminated 3 on April 27, 2017
Recall NumberZ-1487-2017
Recall Event ID 76687
510(K)NumberK142727 
Product Classification Staple, fixation, bone - Product Code JDR
ProductMotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Code Information Lot Number 101868
FEI Number 3020584246
Recalling Firm/
Manufacturer		 Crossroads Extremity Systems Llc
6055 Primacy Pkwy Ste 140
Memphis TN 38119-5702
For Additional Information ContactVernon 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
ActionThe 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 Commerce20 units
DistributionAl, FL, IN, Il, NE, TX, NM, CO, AZ
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JDR
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