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.
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