Device Recall Trident 의 리콜

Recall

46691

Class 2

Z-1169-2008

2008-01-21

2008-06-12

Terminated

United States

2012-09-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68170

Foreign material: some of the parts tested exceeded stryker orthopaedics internal acceptance criteria for manufacturing residuals.

Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.