Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized i

FDA device recall Z-0904-2015 · posted 2015-01-05 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.

Action taken

DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. 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. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT). For questions regarding this recall cal 574-371-4917.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

3861

Distribution

Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malays

Date initiated

2014-11-10

Date posted

2015-01-05

Date terminated

2015-12-08

Location

Warsaw, IN