Zimmer Biomet Recalls Vanguard Knee System Tibial Bearings Due to Labeling Error
Zimmer Biomet is recalling 169 Vanguard Knee System PS Tibial Bearings because the label master file was incorrectly set up, though the physical product is correctly marked.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the physical product is correctly marked and the issue is a documentation error in the label master file, fitting the criteria for minor labeling errors.
Plain-English summary
Zimmer Biomet, Inc. is recalling 169 units of the Vanguard Knee System PS Tibial Bearing, Part Number 183621. These medical devices are intended for use in knee joint replacement procedures. The recall was initiated because the label master file was erroneously configured as a 63/37mm size instead of the correct 63/67mm size. The company notes that there is no 63/37 size offered in the product line, and the physical product is laser marked with the correct size.
The affected units were distributed worldwide, including nationwide distribution in the United States to the states of Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Mississippi, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and West Virginia, as well as to Canada. The recall involves specific lot numbers, including 120150, 140700, 173480, 205730, 294370, 338750, 421970, 516680, 678370, 700470, 722060, 775330, 858220, 888080, and 992290.
This is an FDA Class II recall. Consumers and healthcare providers should check their inventory for these specific part numbers and lot numbers. Since the physical product is correctly laser marked, the issue is limited to the documentation and label master file setup.
The recalled product
- Product
- Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 169
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)
- UDI: (01)00880304673885(17)230222(10)120150
- Lot Number: 120150
- UDI: (01)00880304673885(17)201203(10)140700
- Lot Number: 140700
- UDI: (01)00880304673885(17)211125(10)173480
- Lot Number: 173480
- UDI: (01)00880304673885(17)210520(10)205730
- Lot Number: 205730
- UDI: (01)00880304673885(17)210822(10)294370
- Lot Number: 294370
- UDI: (01)00880304673885(17)210310(10)338750
- Lot Number: 338750
- UDI: (01)00880304673885(17)210902(10)421970
- Lot Number: 421970
- UDI: (01)00880304673885(17)210916(10)516680
- Lot Number: 516680
- UDI: (01)00880304673885(17)210411(10)678370
- Lot Number: 678370
- UDI: (01)00880304673885(17)220603(10)700470
- Lot Number: 700470
Distribution
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