Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,061

FDA device recall Z-0971-2013 · posted 2013-03-19 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.

Action taken

DePuy Orthopaedics sent an Urgent Medical Device Correction Notice letter dated February 5, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the FAX back form to FAX 574-371-4939 or email kseppa@its.jnj.com Questions about device correction information call Post Market Surveillance, 574-372-7333, Sales force questions call Product Specialist, 574-372-7303 and Surgeon questions DePuy's Scientific Information Office at 1-888-554-2482.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

4000; 2600 in USA

Distribution

Worldwide Distribution - USA Nationwide.

Date initiated

2013-02-05

Date posted

2013-03-19

Date terminated

2014-01-06

Location

Warsaw, IN