FDA-Device2019-07-10Class II
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Zimmer Biomet, Inc.
Hazard
There is a potential for weak seals of the sterile packaging.
Sold states
Worldwide Distribution - US Nationwide: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH OK, OR, PA, SC, TN, TX, UT, WA, WI, WV, and Puerto Rico. Products were distributed to the following foreign countries: Australia, Canada, Chile, Japan, Netherlands.
Affected count
3022 total
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2019Don't want to check this manually?
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