Z-0617-2018Class II

Norian Drillable Inject

Name: Z-0617-2018 Norian Drillable Inject
Creator: Synthes USA
Published: 2017-08-10
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2017-08-10 / Terminated / root cause: manufacturing process

FDA source

Synthes USA began a recall of Norian Drillable Inject on 2017-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0617-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-10
Posted: 2018-02-15
Terminated: 2018-09-10
Recalling firm: Synthes (USA) Products LLC
Product: Norian Drillable Inject
Product code: OIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited.
Quantity in commerce: 239 units
Distribution: Nationwide Distribution.
Product codes and lots: Product Number: 07.704.003S Lot Number: DSD9110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0617-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0617-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0618-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code OIS

K102722Class IINorian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC / cleared 2011-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)