—#122071

Product

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032295
Affected lot / code info: Batch No. 12GT20775

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-08-27
Posted by FDA: 2013-12-04
Terminated: 2019-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.