DePuy Attune Impaction Handle Warsaw, IN 46582 Packaging: Product is packed within a polyethylene bag, with protection a

FDA device recall Z-1424-2012 · posted 2012-04-16 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

DePuy Orthopaedics, Inc. is issuing a Recall Notice for nine lots of the Attune" Impaction Handle due to the potential for the handle trigger to break during surgery. The Attune Impactor is provided as a part of a set of tools and is designed specifically for the installation of the Attune Knee

Action taken

DePuy Orthopaedics, Inc. sent an URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE letter dated March 16, 2012 to all consignees affected which extended to the Depuy Distributor level, surgeon and hospital level. The affected DePuy Distributors were notified via email on March 16, 2012. The sales representatives notify hospitals and surgeons by mail or in person with written communication. The letter identified the affected product, reason for recall notice, clinical implications and actions to be taken. Consignees were instructed to complete and return the Response cards to DePuy by fax to 574-372-7567 or email to:kseppa@its.jnj.com. When the new impaction handles are available, the DePuy sales representative will be responsible for providing the new handles, removing and returning the affected handles. For product-related questions, please contact 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.) For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - 5 pm EST.)

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

136 impaction handles

Distribution

USA Nationwide Distribution including the states of: MA, MD, IL, IA, MN, WA, CA, FL, NC, VA, and IN.

Date initiated

2012-03-16

Date posted

2012-04-16

Date terminated

2014-01-09

Location

Warsaw, IN