Z-1170-2008

Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size...

Name: Z-1170-2008 Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-01-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-01-21 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker... on 2008-01-21. The reason FDA records is "Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals". 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-1170-2008
Status: Terminated
Initiated: 2008-01-21
Posted: 2008-06-12
Terminated: 2012-09-25
Recalling firm: Howmedica Osteonics Corp
Product: Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.
Quantity in commerce: 129,312 total shells, all Trident Hemispherical types
Distribution: Nationwide distribution.
Product codes and lots: Catalog Numbers: # 502-01-42A; 42mm; 502-01-44B, 44mm; 502-01-46C, 46mm; 502-01-48D, 48mm; 502-01-50D, 50mm; 502-01-52E, 52mm; 502-01-54E, 54mm; 502-01-56F, 56mm; 502-01-58F, 58mm;, 502-01-60G, 60mm; 502-01-62G, 62mm; 502-01-64H, 64mm; 502-01-66H, 66mm; 502-01-681, 68mm; 502-01-701, 70mm;, 502-01-72J, 72mm; 502-01-74J, 74mm. All lot codes with expiration dates between 1/2005 and 12/2012

Product code MEH

K013676Class IITrident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. / cleared 2001-12-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)