Stryker Recalls Trident Hip Implant Components Due to Documentation Error
Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by a documentation issue for parts that meet all device specifications, which aligns with the rubric's criteria for 'documentation issues' and 'packaging-only problems' classified as Low severity.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 16 units of the Trident 10 degrees X3 Insert 36 mm ID (Catalog #623-10-36I, Lot 3Y0KHP). These are hip implant components that were distributed in Wisconsin.
The recall was initiated because the items were determined to be unacceptable due to a documentation issue, even though they met all device specifications. The parts were inadvertently shipped to the field.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 16
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)
- Lot Code 3Y0KHP
Distribution
Distributed in 1 state:
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