Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches
Stryker is recalling 107 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.
What this means for you
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, and the defect involves a physical characteristic (missing notches) that may affect device function. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 107 units of the Stryker 6.0mm Zyphr Elite Round Fluted Bur, Sterile. The product is identified by Part Number 5820-10-660 and Lot Number 13352017. These 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.
The recall was initiated because there may be missing notches, partial notches, or no notches at all in some of the cutting accessories used with the Elite Attachments. This defect could impact the proper fit or function of the device when used in conjunction with the specified attachments.
The affected units were distributed worldwide, including nationwide distribution in the United States. Healthcare providers and facilities that have received these specific burs should stop using them and contact Stryker for further instructions on return or replacement.
The recalled product
- Product
- Stryker 6.0mm 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 appl
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 107
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 5820-10-660
- Lot Number 13352017
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 →- HighStryker Triton Canister Scanning Labels Recalled Due to Color Variance
FDA (Devices) · 2022-07-27
- ModerateTriton Sponge System Software Instructions Updated for Proper Sponge Handling
FDA (Devices) · 2022-07-27
- HighSurgiCount+ System software error bypasses sponge tracking alerts
FDA (Devices) · 2022-07-27
- SevereStryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
FDA (Devices) · 2020-11-18
- ModerateStryker Neptune E-SEP Blade Electrode Recalled for Expired Product
FDA (Devices) · 2020-05-06
Same hazard · defective design
See all →- ModerateIntegra LifeSciences Recalls CODMAN HAKIM BACTISEAL Shunt Catheters Due to Labeling Error
FDA (Devices) · 2021-04-14
- HighConvaTec Recalls Convex Two-Piece Ostomy Skin Barriers Due to Off-Center Stoma Hole
FDA (Devices) · 2019-11-06
- HighBD Vacutainer Eclipse Blood Collection Needles Recalled for Missing Bevel
FDA (Devices) · 2019-11-06
- HighCook Inc. Recalls Thoracentesis Sets with Small Catheter Holes
FDA (Devices) · 2019-06-12
- HighStryker 3.0mm Round Fluted Bur Recalled for Missing Notches
FDA (Devices) · 2014-06-18