Stryker Recalls Accolade II Hip Stems Due to Packaging Error
Stryker is recalling 20 Accolade II Hip Stems because a Size #3 was found packaged with a Size #5. The error poses a risk of incorrect implant selection.
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 (mis-labeling) without reported injuries, fitting the Moderate severity criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 20 units of Accolade II 127 Neck Angle Hip Stems, specifically Size #3 and Size #5. The recall was initiated after a field report indicated that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
The affected products are intended for cementless application in total or hemiarthroplasty procedures. The recall covers units distributed nationwide, including in Alabama, Georgia, Illinois, and Washington. The specific lot codes involved are 44416307 for Size #3 and 44564405 for Size #5.
Healthcare providers and patients should verify the size of the implanted or packaged device to ensure it matches the surgical plan. Stryker is the recalling firm and can be contacted for further information regarding the recall.
The recalled product
- Product
- 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 20
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)
- 510K K120578 Accolade II I27 Neck Angle Hip Stem
- Size #5 Catalog No. # 6721-0535 Lot Code 44564405
Distribution
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