Biomet Recalls Shoulder Implant Components Due to Endotoxin Levels
Biomet is recalling 122 units of specific shoulder implant components due to potential endotoxin levels exceeding specifications.
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 the hazard involves a high-risk pathogen (endotoxin) without reported illness, meeting the criteria for a High severity score.
Plain-English summary
Biomet, Inc. is recalling 122 units of specific shoulder implant components, including the Hybrid Glenoid Glenoid Base and Comprehensive Reverse Shoulder Humeral Bearings. The recall is being conducted because of the potential presence of elevated endotoxin levels that exceed the specification limit.
The affected products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement. The recall covers specific lot numbers 597000, 502510, and 744880.
These products were distributed worldwide, including in the United States, Canada, India, Japan, Mexico, and other international locations. Healthcare providers and patients should contact Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 122
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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