FDADecember 20, 2017device
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
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