Skip to content
Recall Observatory FDA recall evidence

Device product

Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component

Z-2810-2015

June 25, 2015

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 71754
Status
Terminated
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-2810-2015

Official wording

Reason: it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.

Code information: Lot Code 3Y0KHP

Distribution pattern: Distributed in WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.