FDA-Device2019-12-18Class II
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
Paragon 28, Inc.
Hazard
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Sold states
AR, CA, CO, CT, DC, DE,FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MT, MS, NC, NE, NY, NJ, NV, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY OUS: Australia & Israel
Affected count
64 Wedge Systems
Manufactured in
4B Inverness Ct E Ste 280, N/A, Englewood, CO, United States
Products
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0662-2020Don't want to check this manually?
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