3 — Class II medical device recall Z-2796-2015
Terminated recall by OrthoPediatrics Corp, reported 2015-09-30, distributed in IA, TN. The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different scre
| Recall number | Z-2796-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2015-07-28 |
| Classified | 2015-09-18 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2016-03-17 |
| Distributed | IA, TN |
| Countries outside the US | GB |
| Quantity | 5 |
| Lot numbers | 150192-J |
| Model numbers | 00-0903-2510, 10MM, 3.5MM |
Product
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
Reason for recall
The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
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-2796-2015. 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.