Stryker Recalls Mispackaged Orthopedic Shoulder Trial Instruments
Stryker is recalling 21 units of a shoulder trial instrument because the package contained the wrong part number.
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 hazard is a packaging/labeling error (mispackaging) without reported injuries, fitting the Moderate criteria for minor labeling or packaging issues.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 21 units of the ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, Catalog number 5901-S-4818, Lot MAC7C14. The product is an orthopedic manual surgical instrument manufactured in Cork, Ireland, and distributed nationwide in the United States.
The recall was initiated because a package labeled with the standard humeral head trial part number contained an offset humeral head trial part number (5901-E-4818) instead. This mispackaging error could lead to the use of the wrong surgical instrument during a procedure.
Healthcare facilities and consumers should stop using the affected units and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 21
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)
- Catalog #5901-S-4818
- Lot MAC7C14.
Distribution
Distributed nationwide across the United States.
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