Zimmer Biomet, Inc. recalls Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is u

Recalled April 25, 2018 · FDA recall Z-1381-2018 · Zimmer Biomet

Hazard

There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process. · FDA Class II

Units

1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf

Sold at

Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Australia, South Korea, Malaysia, Netherlands, and Singapore.

Description

There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.

Product

Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.

Manufacturer(s)

Zimmer Biomet, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →