Integra LifeSciences Corp. recalls The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog…

Recall date

December 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1463-2018

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm