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U.S. Department of Health and Human Services

Class 2 Device Recall MotoBand CP, Polyaxial Locking Screw

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  Class 2 Device Recall MotoBand CP, Polyaxial Locking Screw see related information
Date Initiated by Firm September 19, 2019
Create Date October 24, 2019
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = CrossRoads Extremity Systems, LLC
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