Class 2 Device Recall NEXGEN COMPLETE KNEE SOLUTION REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTO

• Date Initiated by Firm: March 14, 2011
• Date Posted: May 10, 2011
• Recall Status: Terminated on August 28, 2013
• Recall Number: Z-2174-2011
• Recall Event ID: 58180
• 510(K)Number: K031061
• Product Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
• Product: NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR , NONSTERILE, REF 00-5901-026-40, Zimmer UK, Ltd., Zimmer Warsaw, IN.; ; Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
• Code Information: 6154826, 61645115 and 61690174.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.
• FDA Determined Cause: Device Design
• Action: The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" notice dated March 14, 2011 to its Consignees/customers. The letter described the product, problem, and the actions to be taken. The customers were instructed to stop using the device and quarantine immediately; carry out a physical count of all affected product in their territory and record this data on the Inventory Return Certification Form and fax to (574) 372-4265; ensure they have provided acknowledgement via "email return receipt" upon receiving notification; return the recalled product along with the completed Inventory Return Certification Form and Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580-Note: The instrument must be returned even if the spring clip is not missing from the instrument; and if they distributed these affected lots further, provide a copy of this letter to the those customers when they implement these recall instructions. The letter stated that a new or refurbished instrument with a redesigned spring clip will be provided as replacement for the recalled device. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc. at 1-800-613-6131.
• Quantity in Commerce: 27 devices
• Distribution: Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden.
• 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 = ZIMMER, INC.