The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1762-2014·Announced 2014-06-18

Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches

Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a specific manufacturing defect (missing notches) without reporting any injuries, illnesses, or serious adverse health consequences, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 39 units of the 3.5mm Zyphr Elite Round Fluted Bur (Sterile). The recall is due to a manufacturing defect where some cutting accessories may have missing notches, partial notches, or no notches at all. These devices are intended to be used to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications.

The affected products are identified by Part Number 5820-10-635 and Lot Number 13354017. The recall covers units distributed worldwide, including nationwide distribution in the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should stop using the affected burs and contact Stryker for instructions on return or replacement. Patients who have had surgery using these specific devices should contact their healthcare provider if they have concerns about the procedure.

The recalled product

Product
Stryker 3.5mm Zyphr Elite 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…
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
39

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part Number 5820-10-635
  • Lot Numbers 13354017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

See all →

Same hazard · manufacturing defect

See all →

Similar recalls