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Terminated

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

FDA Recall Z-1703-2009 · Posted 2009-08-04

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMRA
Date Initiated2009-06-09
Date Terminated2012-05-08
Product Quantity2376 in USA, 1326 internationally

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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