Biomet Reverse Shoulder System Recalled for Potential Sterile Seal Breach
Biomet is recalling specific lots of the Comprehensive Reverse Shoulder System because a breach in the sterile seal could lead to loss of 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 a potential loss of sterility in an implanted device, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Biomet, Inc. is recalling specific lots of the Comprehensive Reverse Shoulder System. The recall involves 7,428 units distributed worldwide, including the United States, Canada, and various international markets.
The recall was initiated because specific lots of these sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility for the device.
Patients who have received these implants should contact their healthcare provider for further evaluation. The affected item numbers include 115394, 115395, 115396, 115398, and a range of 180550 through 180562, excluding 180561.
The recalled product
- Product
- Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient…
- Manufacturer
- Biomet, Inc.
- Affected units
- 7,428
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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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