Z-1944-2016Class II

Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the...

Name: Z-1944-2016 Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the...
Creator: Synthes (USA) Products LLC
Published: 2016-05-11
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-05-11 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the... on 2016-05-11. FDA classified it as Class II and gives the reason as "DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1944-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-11
Posted: 2016-06-09
Terminated: 2017-03-10
Recalling firm: Synthes (USA) Products LLC
Product: Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section by:Fax: 855-695-8597 or Scan/email: [email protected]. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.
Quantity in commerce: 2098 units
Distribution: Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...
Product codes and lots: Catalog ID 07.704.003S, 07.704.005S and 07.704.010S Lot Numbers: DSC1679, DSC3869, DSC7712, DSC8448, DSC9141, DSD0256, DSD2012, DSD2506, DSD3236, DSC1747, DSC1748, DSC2468, DSC3590, DSC3874, DSC6847, DSC7713, DSC8449, DSC9067, DSC9142, DSD0257, DSD0919, DSD2013, DSD2380, DSD3237. DSC1676, DSC2469, DSC3591, DSC3879, DSC8441, DSC9143, DSD0055, DSD0466, DSD1956, DSD2381

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1944-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1942-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09
Z-1943-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09
Z-1944-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09

Product code MQV

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)