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.
What this means for you
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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