Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1944-2016

May 11, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 74172
Status
Terminated
Classification
Class II
Quantity
2098 units
Official record key
device-enforcement:Z-1944-2016

Official wording

Reason: 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.

Code information: 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

Distribution pattern: 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...

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.