Stryker Recalls Accolade Hip Stems Due to Packaging Mix-Up
Stryker is recalling specific Accolade hip stems because size 3.5 stems were mistakenly packaged as size 2.5 stems, creating a risk of product mix-up.
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, which typically corresponds to a moderate severity score. The hazard is a packaging mix-up without reported injuries or illnesses, fitting the criteria for a moderate risk.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling specific units of the Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem. The recall involves Catalog Number 6021-2530 (Lot #40264005) and Catalog Number 6021-3535 (Lot #40163005). The intended use of these devices is for the reconstruction of the head and neck of the femoral joint.
The recall was initiated after Stryker received a report that single size 3.5 stems were packaged as size 2.5 stems. This packaging error resulted in a possible product mix. The source text notes that the lot associated with Catalog Number 6021-3535 was not received in the US.
The affected devices were distributed nationwide, including in the states of New York, New Jersey, California, and Florida. Healthcare providers and facilities should verify the catalog and lot numbers of their inventory against the recall notice to ensure they are not using the affected units.
The recalled product
- Product
- Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
Distribution
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