FDA Device recall Z-0618-2018
Norian Drillable Inject
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Norian Drillable Inject by Synthes Usa, citing 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. So….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0618-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-10 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa |
| Distribution | US |
Product
Norian Drillable Inject
Reason
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.
Identifiers
| code_info | Product Number: 07.704.010S Lot Number: DSE0733 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0618-2018%22
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