Stryker Lindemann Drill Short Recalled for Missing Notches
Stryker is recalling 12 Lindemann Drill Short units 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. The defect involves missing notches on cutting accessories, which is a functional issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 12 units of the Lindemann Drill Short, 1.6mm Sterile. The devices are intended to be used to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications.
The recall is due to a defect where there may be missing notches, partial notches, or no notches at all in some Cutting Accessories used with the Elite Attachments. The affected units are identified by Part Number 5820-102-16 and Lot Number 14006017.
The products were distributed worldwide, including nationwide in the US. The source text does not specify further instructions for consumers or healthcare providers regarding the recall.
The recalled product
- Product
- Lindemann Drill Short, 1.6mm 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
- Hazard
- Affected units
- 12
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 5820-102-16
- Lot Number 14006017
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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