—#82672

Product

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

FDA product code: MRA — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P000013
Affected lot / code info: Literature Number LSP55, all units, no lot number.

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2009-06-09
Posted by FDA: 2009-08-04
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.