Stryker Recalls T2 Basic Long Instrument Sets Due to Mislabeling
Stryker GmbH is recalling 17 T2 Basic Long Instrument Sets because faceplates may incorrectly identify them as T2 Basic Short sets.
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 hazard is a minor labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker GmbH is recalling 17 units of the Instrument Tray, Basic T2 Femur Long (Catalog # 1806-9900), which is used for knee arthroplasty. The recall is due to a labeling error where the faceplates may incorrectly identify the T2 Basic Long Instrument Set as the T2 Basic Short Instrument Set.
The affected products are identified by Lot Number K026ACE (on packaging) and Vendor Code KU97181 (engraved on the device). These units were distributed in Canada and Korea.
Healthcare facilities should stop using the affected instrument sets and contact Stryker for instructions on how to return or replace the products.
The recalled product
- Product
- Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
- Manufacturer
- Stryker GmbH
- Hazard
- Affected units
- 17
Distribution
Distributed in 1 state:
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