Norian Drillable Inject 5 CC-Sterile — Class II medical device recall Z-1943-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-06-15, distributed nationwide. DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers f
| Recall number | Z-1943-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-05-11 |
| Classified | 2016-06-09 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,812 units |
| Reason classes | labeling, sterility |
| Lot numbers | DSC1676, DSC1679, DSC1747, DSC1748, DSC2468, DSC2469, DSC3590, DSC3591, DSC3869, DSC3874, DSC3879, DSC6847, DSC7712, DSC7713, DSC8441, DSC8448, DSC8449, DSC9067, DSC9141, DSC9142, DSC9143, DSD0055, DSD0256, DSD0257, DSD0466, DSD0919, DSD1956, DSD2012, DSD2013, DSD2380, DSD2381, DSD2506, DSD3236, DSD3237 |
| Model numbers | 07.704.003S, 07.704.005S, 07.704.010S |
Product
Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1943-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.