3 — Class II medical device recall Z-2844-2016
Terminated recall by OrthoPediatrics Corp, reported 2016-09-28, distributed nationwide. OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-ho
| Recall number | Z-2844-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2016-07-27 |
| Classified | 2016-09-19 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 41 |
| Reason classes | labeling |
| Lot numbers | NM02346 |
Product
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
Reason for recall
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
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-2844-2016. 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.