Biomet Recalls Hip Components Due to Incorrect GTIN Labeling Codes
Biomet is recalling specific hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 indicates the product is not likely to cause adverse health consequences. The issue is limited to incorrect labeling codes (GTIN) and does not involve a physical defect or contamination that poses a direct safety risk.
Plain-English summary
Biomet, Inc. is recalling specific Mallory/Head Primary Hip System and Mallory/Head Total Hip System components. The recall involves 1,315 units of femoral stems, femoral heads, acetabular shells, and acetabular liners. The specific items affected are Size 11, 160 mm, Lateralized Femoral Stem (Ti-6Al-4V; Porous Plasma Uncemented) and Size 12, 165 mm, Bi-Metric Femoral Components.
The reason for the recall is that the device labeling contains incorrect Global Trade Identification Number (GTIN) codes. This is a labeling error rather than a defect in the physical construction or material of the implant components.
The affected products were distributed worldwide, including in the United States and various international markets. The specific lot numbers involved are 127340, 182030, and 349650, with a use-by date of March 18, 2025. Healthcare providers and patients should verify the part numbers (11-104212 & 11-104211) and lot numbers of any implanted or pending components to determine if they are affected.
The recalled product
- Product
- Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 1,315
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: 11-104212 & 11-104211
- 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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