Z-2810-2015Class II

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

Name: Z-2810-2015 Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-06-25
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-06-25 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component on 2015-06-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2810-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-25
Posted: 2015-09-23
Terminated: 2017-08-30
Recalling firm: Howmedica Osteonics Corp
Product: Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.
Quantity in commerce: 16 units
Distribution: Distributed in WI.
Product codes and lots: Lot Code 3Y0KHP

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2810-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2810-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23

Product code LPH

K033716Class IITrident Acetabular SystemHowmedica Osteonics Corp. / cleared 2005-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)