Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Reported: December 3, 2014 Initiated: October 14, 2014 #Z-0424-2015
Product Description
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 4961 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.. Recalled by Zimmer, Inc.. Units affected: 4961 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0424-2015.
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