Recall Z-1463-2018— Integra LifeSciences Corp.

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2017-12-20, terminated 2020-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..

Recalling firm

Integra LifeSciences Corp.

Classification

Class II

Status

Terminated

Initiated

2017-12-20

Terminated

2020-02-24

Firm location

Plainsboro, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.