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U.S. Department of Health and Human Services

Class 2 Device Recall The HemiCAP Contoured Articular Prosthetic

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  Class 2 Device Recall The HemiCAP Contoured Articular Prosthetic see related information
Date Initiated by Firm November 24, 2014
Date Posted February 12, 2015
Recall Status1 Terminated 3 on March 27, 2015
Recall Number Z-1114-2015
Recall Event ID 69723
510(K)Number K023096  
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
Product Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Code Information Catalog Number: 8156-0032, Part Number: 156-0032
Recalling Firm/
Manufacturer		 Arthrosurface, Inc.
28 Forge Pkwy
Franklin MA 02038
For Additional Information Contact
508-520-3003
Manufacturer Reason
for Recall		 Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
FDA Determined
Cause 2		 No Marketing Application
Action Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
Quantity in Commerce 187
Distribution Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
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 = HSD and Original Applicant = STD MFG., INC.
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