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Class 2 Device Recall PROMOS Releasing Clamp (3 parts) |
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Date Initiated by Firm |
November 21, 2008 |
Date Posted |
February 03, 2009 |
Recall Status1 |
Terminated 3 on November 27, 2012 |
Recall Number |
Z-0960-2009 |
Recall Event ID |
50545 |
510(K)Number |
K081016
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Product Classification |
shoulder prosthesis - Product Code KWS
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Product |
PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile
Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer |
Code Information |
Lot numbers: A1, A1B1107, A2, A3B1107, A3, A3B1107, A4, A4/I, A51767, A51767B706, B57815, B58460, B60400, and B62141 |
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
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Manufacturer Reason for Recall |
The product was breaking during use.
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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 |
159 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 and Original Applicant = SMITH & NEPHEW, INC.
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