Integra LifeSciences Recalls Humeral Stem Trials for Breakage Risk
Integra LifeSciences is recalling 1,619 humeral stem trials for the Titan Modular Shoulder System because they may break during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (surgical delay and intervention) without reported hospitalizations or fatalities, fitting the High severity criteria.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,619 units of humeral stem trials packaged in the Titan Modular Shoulder System kit. The affected products are identified by catalog numbers TRL092002506 through TRL092002516 and specific lot numbers listed in the agency's recall record. The recall covers units distributed nationwide in the United States.
The recall was initiated after incidents of stem trial breakage were reported to the firm. These fractures reportedly occurred during the insertion, impaction, or extraction of the humeral stem trial while preparing the humeral canal or trialing. All reported cases resulted in a delay in surgery and required a variance in medical intervention.
Healthcare providers should stop using the affected humeral stem trials and contact Integra LifeSciences Corp. for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- 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…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 1,619
Distribution
Distributed nationwide across the United States.
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