Date Initiated by Firm | November 24, 2014 |
Date Posted | February 12, 2015 |
Recall Status1 |
Terminated 3 on March 27, 2015 |
Recall Number | Z-1110-2015 |
Recall Event ID |
69723 |
510(K)Number | K023096 |
Product Classification |
Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
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Product | Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component. |
Code Information |
Catalog Number: 6105-0028, Part Number 1105-0028 |
Recalling Firm/ Manufacturer |
Arthrosurface, Inc. 28 Forge Pkwy Franklin MA 02038
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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 | 136 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = HSD
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