Modera Modular Pedicle Screw System Shank Insertion Instrument — Class II medical device recall Z-2604-2018
Terminated recall by New Era Orthopaedics, LLc, reported 2018-08-15, distributed in CO, TX. This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Sc
| Recall number | Z-2604-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Era Orthopaedics, LLc, Hummelstown, PA, United States |
| Recall initiated | 2017-02-13 |
| Classified | 2018-08-03 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2018-11-07 |
| Distributed | CO, TX |
| Quantity | 6 units |
Product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Reason for recall
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.
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-2604-2018. 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.