Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
P28 Recalled by Paragon 28, Inc. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Paragon 28, Inc. directly.
Affected 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
Quantity: 64 Wedge Systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 34 states: AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, MD, MA, MI, MS, MT, NE, NV, NJ, NY, NC, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY, DC
About Paragon 28, Inc.
Paragon 28, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report