Stryker 5.0mm Egg Bur Recall Due to Missing Notches
Stryker is recalling 144 units of 5.0mm Egg Bur sterile devices because some cutting accessories may have missing or partial notches.
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, and the defect involves a physical characteristic (missing notches) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 144 units of the Stryker 5.0mm Egg Bur Sterile device. The recall is due to a manufacturing defect where some Cutting Accessories used with the Elite Attachments may have missing notches, partial notches, or no notches at all.
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. The specific part number is 5820-15-50 and the lot number is 13343017.
The affected units were distributed worldwide, including nationwide in the United States. Healthcare providers and facilities should stop using the affected devices and contact Stryker for further instructions on the recall.
The recalled product
- Product
- Stryker 5.0mm Egg 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 144
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 5820-15-50
- Lot Number 13343017
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 · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateStryker Surgical Burs Recalled Due to Package Label Mismatch
FDA (Devices) · 2025-01-29
- ModerateStryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion
FDA (Devices) · 2016-12-28
- HighStryker neurosurgical device labeling mismatch: wrong instruments shipped
FDA (Devices) · 2025-01-29
- SevereStryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns
FDA (Devices) · 2018-04-04
- HighStryker Locking Screw Recall Due to Compromised Sterility
FDA (Devices) · 2020-06-24
- HighStryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues
FDA (Devices) · 2020-02-19