The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of

FDA device recall Z-0930-2012 · posted 2012-01-30 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

All lots of DePuy, SIGMA HP Fixed Bearing Tibial Tray Impactors are being recalled because the impactor can become intentionally locked on the Tibial Tray implant during surgery.

Action taken

The firm, DePuy, sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" email dated December 13, 2011 to its customers. The email notice described the product, problem and actions to be taken. The customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN; follow the instructions provided and complete and return the Fax Back Response card via fax to: 574-372-7567 or email: kseppa@its.jnj.com by December 23, 2011. For questions about recall information provided, please contact Manager of Customer Quality at 574-372-7333 (M-F; 8 am - 5 pm EST.) For product-related questions from Sales force, please contact Group Product Director at 574-372-7538 (M-F; 8 am - 5 pm EST.) or your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact DePuy's Scientific Information Office at 1-888-554-2482 (M-F; 8 am - 5 pm EST.)

Root cause

Device Design

Status

Terminated

Product code

HWA

Quantity affected

1794

Distribution

Worldwide distribution: USA (nationwide) and countries of: Canada, Ireland and South Africa.

Date initiated

2011-12-13

Date posted

2012-01-30

Date terminated

2013-07-12

Location

Warsaw, IN