Recall Z-0662-2020 · PLF Bone Wedge
Paragon 28, Inc.
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
| Date | Dec 10, 2019 (initiated Sep 28, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | On September 19th, 2018 Paragon 28 issued a Recall Letter to consignees via email and physical mail. The letter informed consignees of the product mislabeling issue. They were instructed to immediately take the following actions: 1. Review inventory of the TITAN 3D Wedge implants to determine if they possess affected product. 2. If they possess the affected product, return product to Paragon 28 for disposition 3. Regardless, if they have or do not have affected recall product, complete and return an acknowledgement form to Paragon 28 |
| Quantity | 64 Wedge Systems |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162241 | TITAN 3-D Wedge System Paragon 28, Apr 3, 2017 |