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U.S. Department of Health and Human Services

Class 2 Device Recall NEXGEN COMPLETE KNEE SOLUTION QUICKCONNECT HANDLE

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 Class 2 Recall
NEXGEN COMPLETE KNEE SOLUTION QUICKCONNECT HANDLE
see related information
Date Posted April 14, 2011
Recall Status1 Terminated on March 19, 2013
Recall Number Z-1989-2011
Recall Event ID 58225
Premarket Notification
510(K) Number
K031061 
Product Classification Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer - Product Code MBH
Product Posterior Referencing Instrumentation for the NEXGEN® COMPLETE KNEE SOLUTION QUICK-CONNECT HANDLE, REF 00-5901-034-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Code Information REF 00-5901-034-00, Lots 61501824, 61542065, 61550601, 61575890, 61585376, 61612789, 61615894, 61626378, 61634995, 61635431, 61648520, 61657310, 61660292, 61675232 and 61682485.
Recalling Firm/
Manufacturer
Zimmer Inc.
1800 W Center St
Warsaw, Indiana 46580-2304
Manufacturer Reason
for Recall
The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Instructions for Handling of Affected Product: 1) Stop using the devices and to quarantine immediately 2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder 3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification 4) Fax copy of completed form to (574) 372-4265 5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580 A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available. Instructions for Health Care Professional Notification 1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form 2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265 Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons. Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131. ADDENDUM INFO The information listed above was updated to include the additional 5 .
Quantity in Commerce 757
Distribution Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = ZIMMER, INC.
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