Z-1703-2009

Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55

Name: Z-1703-2009 Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-06-09
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-06-09 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55 on 2009-06-09. The reason FDA records is "The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1703-2009
Status: Terminated
Initiated: 2009-06-09
Posted: 2009-08-04
Terminated: 2012-05-08
Recalling firm: Howmedica Osteonics Corp
Product: Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.
Product code: MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Reason for recall: The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Stryker sent Urgent - Product Correction - Surgical Protocol letters by Federal Express on June 9, 2009 to all Stryker branches/agencies, hospital Risk Management, hospital Chief of Orthopaedics, surgeons and all foreign consignees.
Quantity in commerce: 2376 in USA, 1326 internationally
Distribution: Worldwide distribution.
Product codes and lots: Literature Number LSP55, all units, no lot number.

Product code MRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)