Stryker Scorpio femoral component recall due to blister seal strength
Stryker Howmedica Osteonics is recalling 1,147 Scorpio femoral components because the inner blister peel strength may be below validated requirements, potentially affecting sterile barrier shelf life.
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, but the hazard is a potential packaging defect (blister seal strength) affecting shelf life rather than a direct structural failure or reported injury, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 1,147 units of the Stryker Orthopaedics Scorpio femoral component. These sterile components are used for total reconstructive replacement of the knee joint. The recall is due to a potential defect where the peel strength of the inner blister may have been below internal validated requirements.
The strength of the seal is directly related to the long-term shelf life of the sterile barrier. The affected products were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
Healthcare providers and facilities should check their inventory for the specific item numbers and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Stryker Howmedica Osteonics Corp. according to their instructions.
The recalled product
- Product
- Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 1,147
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 (20)
- Item number 26-3005L Lot numbers MNH0ND
- MNH3V7
- MNH8XR
- MNHN0E
- MNH6Y5
- 70-3003L Lot MNE6NM
- 70-3003R Lot MNE963
- 70-3007L Lots MNE58K
- MNE6HL
- MNE8MN
- MNEKXP
- 70-3007R Lots MNEV2Y
- MNEVDV
- MNEN3D
- MNEX43
- 70-3013L Lot MMMXTY
- 70-4104L Lots MNE0Y8
- MNE2J2
- MND743
- MNDVDT
Distribution
Part of a larger recall action
This product is one of 3 recalled by Stryker Howmedica Osteonics Corp. 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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