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U.S. Department of Health and Human Services

Class 2 Device Recall PROMOS Releasing Clamp (3 parts)

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  Class 2 Device Recall PROMOS Releasing Clamp (3 parts) see related information
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  
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
Recalling Firm/
Smith & Nephew Inc
1450 Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor Rocha
Manufacturer Reason
for Recall
The product was breaking during use.
FDA Determined
Cause 2
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 and Original Applicant = SMITH & NEPHEW, INC.