medical Class II Updated 2019-12-18

Paragon 28, Inc. recalls P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected 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
Lot/Code Info: Lot # BR4108
View official government recall

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