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U.S. Department of Health and Human Services

Class 2 Device Recall ATTUNE" Articulation Surface

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  Class 2 Device Recall ATTUNE" Articulation Surface see related information
Date Initiated by Firm June 12, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 on November 12, 2015
Recall Number Z-2146-2015
Recall Event ID 71421
510(K)Number K140881  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
Product ATTUNE CONV FB CR TB TRL SZ3 - 10

INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
Code Information Product Codes:254501963, 254501964, 254501965, 254501966, 254501967, 254501968, 254501969, and 254501970. GTIN: 10603295423355, 10603295423362, 10603295423379, 10603295423386, 10603295423393, 10603295423409, 10603295423416, and 10603295423423.
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy K. Tinsley
574-267-8143
Manufacturer Reason
for Recall		 Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
FDA Determined
Cause 2		 Device Design
Action URGENT INFORMATION: MEDICAL DEVICE CORRECTION was issued for all lots of the affected devices. The device correction is to inform US Distributors and Medical Professionals about the issue, how to prevent the issue, and any actions to take. US Distributors will provide Hospitals/User Facilities with the Medical Professional Notice and Acknowledgment Cards. US Distributors will also work with the sales consultants to ensure all consultants complete sales training regarding this issue.
Quantity in Commerce 14756 units
Distribution Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = DEPUY (IRELAND)
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