Recalls / —

—#122572

Product

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K951987

Affected lot / code info

Batch No. 13GM09505

Why it was recalled

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Root cause (FDA determination)

Process control

Action the firm took

Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.

Recalling firm

Firm

Smith & Nephew Inc

Address

1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern

USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.

Timeline

Recall initiated

2013-10-07

Posted by FDA

2013-11-01

Terminated

2016-08-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #122572. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.