ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyet

FDA device recall Z-0199-2015 · posted 2014-11-10 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.

Action taken

DePuy sent an "URGENT DEVICE CORRECTION" notifications dated October 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please call 574-371-4917.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

3,082

Distribution

Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malay

Date initiated

2014-10-15

Date posted

2014-11-10

Date terminated

2015-11-19

Location

Warsaw, IN