Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.
FDA device recall Z-1703-2009 · posted 2009-08-04 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MRA
- Quantity affected
- 2376 in USA, 1326 internationally
- Distribution
- Worldwide distribution.
- Date initiated
- 2009-06-09
- Date posted
- 2009-08-04
- Date terminated
- 2012-05-08
- Location
- Mahwah, NJ
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