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U.S. Department of Health and Human Services

Class 2 Device Recall VSP Reconstruction, Scapula Marking Guide (Anatomically Shaped)

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 Class 2 Device Recall VSP Reconstruction, Scapula Marking Guide (Anatomically Shaped)see related information
Date Initiated by FirmMay 17, 2022
Create DateAugust 09, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1510-2022
Recall Event ID 90672
510(K)NumberK133907 
Product Classification Driver, wire, and bone drill, manual - Product Code DZJ
Product3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Code Information Lot # 167559; UDI: (01) 00816847020886
FEI Number 3003142829
Recalling Firm/
Manufacturer		 Medical Modeling, Inc.
5381 S Alkire Cir
Littleton CO 80127-1403
For Additional Information ContactPatricia Fleenor
303-273-5344
Manufacturer Reason
for Recall		Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
FDA Determined
Cause 2		Employee error
ActionOn May 17, 2022, Medical Modeling - A 3D systems Company representative contacted affected customer via phone and informed the consignee of the issue and their plan to remove the device and provide a new one.
Quantity in Commerce1 unit
DistributionInternational distribution in the country of Germany.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DZJ
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