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Trident Acetabular System Surgical Protocol. Instructions… recallZ-1703-2009 · Stryker Howmedica Osteonics Corp. · initiated Jun 9, 2009

Terminated All recalls posted in August 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number
Z-1703-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 9, 2009
Posted by the FDA
Aug 4, 2009
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
2376 in USA, 1326 internationally
Product code
MRA
FDA submissions
P000013
Distribution
Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

Literature Number LSP55, all units, no lot number.

Other devices under the same FDA submission

5 devices cleared under P000013 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page