CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Norian Drillable Inject recalled by Synthes U
Synthes U is recalling Norian Drillable Inject, distributed nationwide in the US. The recall was initiated on 10 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0617-2018
- FDA event ID
- 79043
- Recalling firm
- Synthes U, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2017
- FDA classified
- 15 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2017 | Recall initiated by company | |
| 15 Feb 2018 | Classified by FDA | +189 days |
| 21 Feb 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Norian Drillable Inject
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is Norian Drillable Inject recalled?
Yes. Synthes U recalled Norian Drillable Inject on 10 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0617-2018.
Why was it recalled?
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.
Which lots are affected?
Product Number: 07.704.003S Lot Number: DSD9110
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Synthes U
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Norian Drillable Inject recalled by Synthes U | Synthes U | Other | Nationwide |
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