FDA Device recall Z-1944-2016
Norian Drillable Inject 10 CC-Sterile
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Norian Drillable Inject 10 CC-Sterile by Synthes Usa Products, citing 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 withi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1944-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-11 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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.
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.
Identifiers
| code_info | Catalog ID 07.704.003S, 07.704.005S and 07.704.010S Lot Numbers: DSC1679, DSC3869, DSC7712, DSC8448, DSC9141, DSD0256,…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 |
|---|
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-1944-2016%22
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