Biomet Knee Joint Replacement Components Recalled for Incorrect GTIN Codes
Biomet is recalling MCK Maximum Congruent Knee System 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 is defined as unlikely to cause adverse health consequences. The issue is a documentation/labeling error (incorrect GTIN codes) with no reported injuries or illnesses.
Plain-English summary
Biomet, Inc. is recalling specific components of the MCK Maximum Congruent Knee System, including femoral, tibial, and patellar components. The recall involves 1,315 units of the Biomet Finned PRI Stem in various sizes (40mm; 80 x 10mm; 80 x 12.5 mm; 80 x 15 mm).
The reason for the recall is that the device labeling contains incorrect Global Trade Identification Number (GTIN) codes. The affected products were distributed worldwide, including nationwide in the United States and in countries such as Canada, Japan, and various European nations.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses, injuries, or deaths are reported in the source text.
The recalled product
- Product
- MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
- 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 (20)
- Part Numbers: 141314
- 141316
- 141318
- 141320
- Use-by 2025-03-13
- Lot Numbers: 035650
- 035690
- 065500
- 066850
- 066900
- 066910
- 066930
- 066940
- 066950
- 066960
- 066970
- 066990
- 067010
- 104580
- 104590
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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