Stryker Recalls Trident PSL Hip Shells Missing Dome Hole Plugs
Stryker Howmedica Osteonics is recalling seven units of Trident PSL HA Solid Back 50 mm hip shells because the dome hole plugs were missing from the packages.
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 issue involves missing components (dome hole plugs) which constitutes a minor labeling/packaging error or low-risk contamination rather than a direct injury hazard or high-risk pathogen.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling seven units of the Trident PSL HA Solid Back 50 mm acetabular shell system, reference number 540-11-50E, lot code 49073501. This medical device is intended for cementless application in total hip arthroplasty procedures and consists of a shell and a liner.
The recall was initiated after five customer complaints were received regarding the same batch of shells. The complaints alleged that when the packages were opened, the dome hole plugs were not present. The affected units were distributed nationwide, including in New York, Ohio, Pennsylvania, and Texas.
Healthcare providers and patients should check their inventory for this specific lot number and reference number. If the dome hole plug is missing from the package, the device should not be used. Stryker Howmedica Osteonics is the recalling firm responsible for this action.
The recalled product
- Product
- Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patie
- Manufacturer
- Stryker Howmedica Osteonics Corp.
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 (1)
- 510K 983382 Lot code 49073501
Distribution
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