Device 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
Z-0662-2020
Product summary
- Firm
- Paragon 28, Inc.
- Event
- Event 84234
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 Wedge Systems
- Official record key
device-enforcement:Z-0662-2020
Official wording
Reason: 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.
Code information: Lot # BR4108
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
mislabeled