Data Foundry

Medical device recalls 2019

CORAIL AMT HIGH OFFSET NECK SEGMENT — Class II medical device recall Z-1129-2019

Terminated recall by DePuy Orthopaedics, Inc., reported 2019-04-17, distributed nationwide. There is the potential for debris/material to be found behind the O-rings in the neck trials.

Recall numberZ-1129-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDePuy Orthopaedics, Inc., Warsaw, IN, United States
Recall initiated2018-09-21
Classified2019-04-11
Reported by FDA2019-04-17
Terminated2020-04-22
DistributedNationwide (US)
Quantity12,639 total

Product

CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

Reason for recall

There is the potential for debris/material to be found behind the O-rings in the neck trials.

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-1129-2019. 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.