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U.S. Department of Health and Human Services

Class 2 Device Recall ATTUNE INTUITION

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 Class 2 Device Recall ATTUNE INTUITIONsee related information
Date Initiated by FirmNovember 10, 2014
Date PostedJanuary 12, 2015
Recall Status1 Terminated 3 on December 08, 2015
Recall NumberZ-0953-2015
Recall Event ID 70014
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductThe ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.
Code Information CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324
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		Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
FDA Determined
Cause 2		Device Design
ActionOn 11/10/2014, URGENT INFORMATION ATTUNE INTUITION IMPACTION HANDLE AND IMPACTORS DEVICE CORRECTION NOTICE notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. 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 contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
Quantity in Commerce7,944
DistributionWorldwide Distribution-US (nationwide) except AK and RI, including PR and the countries of Chile, Canada, Australia, Austria, Belgium, France, Hong Kong, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Saudi Arabia, 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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