Stryker Wire Pass Drill Recalled for Missing Notches
Stryker is recalling 246 sterile 1.5mm Wire Pass Drills 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. The defect involves missing notches on a surgical instrument, which is a functional issue but does not explicitly report injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 246 units of the 1.5mm Wire Pass Drill, sterile. The devices are intended to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications. The recall is due to a manufacturing defect where some cutting accessories used with Elite Attachments may have missing notches, partial notches, or no notches at all.
The affected products are identified by Part Number 5820-103-15 and Lot Number 14004017. The distribution pattern is listed as worldwide, including nationwide distribution in the US. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare providers and facilities should stop using the affected devices and contact Stryker for instructions on return or replacement. Consumers are not directly affected as these are professional medical devices used in surgical settings.
The recalled product
- Product
- Stryker 1.5mm Wire Pass Drill 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 246
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 5820-103-15
- Lot Number 14004017
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.
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