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U.S. Department of Health and Human Services

Class 2 Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactor

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 Class 2 Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactorsee related information
Date Initiated by FirmNovember 10, 2014
Date PostedJanuary 05, 2015
Recall Status1 Terminated 3 on December 08, 2015
Recall NumberZ-0903-2015
Recall Event ID 70043
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductFixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
Code Information CATALOG NO. : ATTUNE INTUITION Impactors  Fixed Tibial Bearing, (254401003)  Barcode GTIN Number:  Fixed Tibial Bearing, ......... 10603295130192   ALL LOTS
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactKimberly C. Earle
574-371-4917
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionDePuy 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.
Quantity in Commerce4555
DistributionWorldwide 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, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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