Zimmer, Inc. recalls The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arth

Recalled October 29, 2014 · FDA recall Z-0123-2015 · Zimmer

Hazard

Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. · FDA Class II

Units

618 units

Sold at

Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan

Description

Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.

Product

The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.

Manufacturer(s)

Zimmer, Inc.

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