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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal Tibial Impactor

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  Class 2 Device Recall Trabecular Metal Tibial Impactor see related information
Date Initiated by Firm October 14, 2014
Date Posted November 24, 2014
Recall Status1 Terminated 3 on June 09, 2015
Recall Number Z-0423-2015
Recall Event ID 69366
Product Classification Impactor - Product Code HWA
Product Trabecular Metal Tibial Impactor.

Product Usage:
TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Code Information Item 00-5953-056-00; all lots
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Customer Call Center
877-946-2761
Manufacturer Reason
for Recall		 To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
FDA Determined
Cause 2		 Labeling design
Action On 10/14/2014, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected distributors and hospital Risk Managers. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. 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, call the customer call center at 1-877-946-2761.
Quantity in Commerce 1165 units
Distribution Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.
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.
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