—#120009

Product

GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot Number 12LM03798

Why it was recalled

The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Smith & Nephew sent an Urgent Recall Notification letter dated July 8, 2013 to all affected customers. Surgeons were notified by letter beginning on July 16, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, locate unused devices, quarantine immediately, and return affected product to the address provided in the notification. For questions email to FieldActions@smith-nephew.com.

Recalling firm

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

Distribution

Distribution pattern: International only: Germany, France, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2013-07-08
Posted by FDA: 2013-08-22
Terminated: 2019-08-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120009. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.