PlainRecalls
FDA Devices Moderate Class II Terminated

Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.

Reported: October 8, 2014 Initiated: September 9, 2014 #Z-2737-2014

Product Description

Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.

Reason for Recall

The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
16,380 units
Distribution
Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.. Recalled by Zimmer, Inc.. Units affected: 16,380 units.
Why was this product recalled?
The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 8, 2014. Severity: Moderate. Recall number: Z-2737-2014.