Z-1751-2014 Class II Terminated
FDA device recall Z-1751-2014 was initiated by Stryker Instruments Div. Of Stryker Corporation on May 22, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 6, 2015). Affected quantity: 252.
Recall details
- Product Type
- Devices
- Report Date
- Jun 18, 2014
- Initiation Date
- May 22, 2014
- Termination Date
- May 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 252
Product description
Stryker 2.0mm Round Fluted Bur 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.
Distribution pattern
Worldwide Distribution - US (nationwide)
Code information
Part Number 5820-10-20, Lot Numbers 13347017,14010017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1751-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026