The Recall Desk
LowFDA (Devices)·Z-2810-2015·Announced 2015-09-30

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.

What this means for you

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
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: