Stryker 3 — Class II medical device recall Z-1775-2014
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2014-06-18, distributed nationwide. There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used w
| Recall number | Z-1775-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2014-05-22 |
| Classified | 2014-06-10 |
| Reported by FDA | 2014-06-18 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 802 |
| Lot numbers | 13351017, 14007017 |
| Model numbers | 5820-107-30 |
Product
Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Reason for recall
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
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-1775-2014. 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.