Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0423-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: October 14, 2014
Date Posted: December 3, 2014
Recall Number: Z-0423-2015
Event ID: 69366
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.

Status: Terminated
Product Quantity: 1165 units
Code Information:

Item 00-5953-056-00; all lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated