Biomet Shoulder Surgery Pliers Recalled for Sterility Concerns
Biomet is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers replacement tips due to unknown bioburden levels that may affect sterility.
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. The hazard involves potential sterility failure in a surgical device, which poses a risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522. These medical devices are intended for use in surgery to relieve pain and replace the glenoid and humeral side of the shoulder joint to restore mobility in patients with specific joint conditions.
The recall was initiated because there were unknown bioburden levels prior to sterilization, which may affect the sterility of the product. The affected units were distributed worldwide, including nationwide in the United States and in Australia, Canada, India, and the Netherlands.
Healthcare providers and patients should stop using the affected replacement tips and contact Biomet, Inc. for further instructions. The recall covers specific lot numbers, including 494350, 494350R, 233080, 364910, 489000, 079630, 516230, 742760, 362370, 465800, 197900, 175110, and 175100.
The recalled product
- Product
- Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff…
- Manufacturer
- Biomet, Inc.
- Affected units
- 125
Distribution
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