• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ATTUNE" Articulation Surface

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ATTUNE" Articulation Surfacesee related information
Date Initiated by FirmJune 12, 2015
Date PostedJuly 20, 2015
Recall Status1 Terminated 3 on November 12, 2015
Recall NumberZ-2140-2015
Recall Event ID 71421
510(K)NumberK140881 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
ProductATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 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:254500981, 254500982, 254501989, and 254501990. GTIN: 10603295135586, 10603295135593, 10603295423492, and 10603295423959.
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactMindy 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
ActionURGENT 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 Commerce13964 units
DistributionWorldwide 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 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.
510(K) Database510(K)s with Product Code = MBH
-
-