Data Foundry

Medical device recalls 2018

Norian Drillable Inject — Class II medical device recall Z-0617-2018

Terminated recall by Synthes USA, reported 2018-02-21, distributed nationwide. The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with

Recall numberZ-0617-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSynthes USA, West Chester, PA, United States
Recall initiated2017-08-10
Classified2018-02-15
Reported by FDA2018-02-21
Terminated2018-09-10
DistributedNationwide (US)
Quantity239 units
Lot numbersDSD9110

Product

Norian Drillable Inject

Reason for recall

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

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-0617-2018. 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.