Class 2 Device Recall PROMOS Releasing Clamp (3 parts)

• Date Initiated by Firm: November 21, 2008
• Date Posted: February 03, 2009
• Recall Status: Terminated on November 27, 2012
• Recall Number: Z-0960-2009
• Recall Event ID: 50545
• 510(K)Number: K081016
• Product Classification: shoulder prosthesis - Product Code KWS
• 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
• FEI Number: 1020279
• Recalling Firm/ Manufacturer: Smith & Nephew Inc; 1450 Brooks Rd; Memphis TN 38116
• For Additional Information Contact: Victor Rocha; 901-399-6771
• Manufacturer Reason for Recall: The product was breaking during use.
• FDA Determined Cause: 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

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 = KWS