P28 — Class II medical device recall Z-0662-2020
Terminated recall by Paragon 28, Inc., reported 2019-12-18, distributed in AR, CA, CO, CT, DC, DE, FL, GA…. It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge imp
| Recall number | Z-0662-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragon 28, Inc., Englewood, CO, United States |
| Recall initiated | 2018-09-28 |
| Classified | 2019-12-10 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2020-08-20 |
| Distributed | AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY |
| Countries outside the US | AU, IL |
| Quantity | 64 wedge |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889795018182 |
| Lot numbers | BR4108 |
| Model numbers | P03-EVN-1010-S |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0662-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.