| Class 2 Device Recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT | |
Date Initiated by Firm | August 27, 2013 |
Date Posted | December 04, 2013 |
Recall Status1 |
Terminated 3 on August 20, 2019 |
Recall Number | Z-0445-2014 |
Recall Event ID |
66333 |
510(K)Number | K032295 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic |
Code Information |
Batch No. 12GT20824 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
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For Additional Information Contact | Joe Metzger 901-396-2121 Ext. 5373 |
Manufacturer Reason for Recall | The Tyvek(TM) lid on one, or both, of the two trays that form a
double barrier around the insert may not have been adequately sealed.
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FDA Determined Cause 2 | Package design/selection |
Action | Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email.
For questions regarding this recall call 901-396-2121. |
Quantity in Commerce | 45 pieces |
Distribution | Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom. |
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 = JWH
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