Biomet Shoulder Joint Replacement Components Recalled for Incorrect GTIN Codes
Biomet, Inc. is recalling specific shoulder joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error (incorrect GTIN) rather than a physical defect or contamination.
Plain-English summary
Biomet, Inc. is recalling two units of the Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. These shoulder joint replacement components include humeral stems, humeral heads, and glenoid components. The recall is due to incorrect Global Trade Identification Number (GTIN) codes on the device labeling.
The affected products are identified by Part Number 113644, with Lot Numbers 127340, 182030, and 349650. The use-by date for these items is March 18, 2025. The products were distributed worldwide, including in the United States and various international locations such as Europe, Canada, Japan, and Australia.
This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences. Consumers and healthcare providers should verify the part and lot numbers of their inventory against the recall details provided.
The recalled product
- Product
- Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Part Numbers: 113644
- Use-by 2025-03-18
- Lot Numbers: 127340
- 182030
- 349650.
Distribution
Part of a larger recall action
This product is one of 4 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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