Reported Jun 18, 2014 · Terminated

Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue…

Stryker Instruments Div. of Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704

Stryker 5.0mm
Acorn Bur Sterile Product UsageThe 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

The agency filed one notice per product. You are reading one of them; the other 31 are below.

19 more are in the archive.

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

47 in total.