GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 714304

FDA device recall Z-1996-2013 · posted 2013-08-22 · Terminated

Recall details

Recalling firm

Smith & Nephew Inc

Reason for recall

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).

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

JWH

Quantity affected

9 units

Distribution

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

Date initiated

2013-07-08

Date posted

2013-08-22

Date terminated

2019-08-19

Location

Memphis, TN