| Class 2 Device Recall PROMOS Reverse, Glenosphere Loosening Adapter | |
Date Initiated by Firm | November 21, 2008 |
Date Posted | February 03, 2009 |
Recall Status1 |
Terminated 3 on November 27, 2012 |
Recall Number | Z-0961-2009 |
Recall Event ID |
50545 |
510(K)Number | K081016 |
Product Classification |
shoulder prosthesis - Product Code KWS
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Product | PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile
Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer |
Code Information |
Lot numbers: A55827, A59222, A62005, A62127, A62349, A63526, and A63779 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 Brooks Rd Memphis TN 38116
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For Additional Information Contact | Victor Rocha 901-399-6771 |
Manufacturer Reason for Recall | The product was breaking during use. |
FDA Determined Cause 2 | Other |
Action | All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance. |
Quantity in Commerce | 51 units |
Distribution | Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress |
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 = KWS
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