Zimmer Biomet Recalls ArComXL Polyethylene Bearings Due to Labeling Mismatch
Zimmer Biomet is recalling 19 ArComXL Polyethylene Bearings because packaging labels did not match the physical product inside, posing a risk of surgical delay.
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 involves a labeling error that poses a risk of surgical delay but does not involve direct physical injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19 units of Active Articulation ArComXL Polyethylene Bearings (Item XL-200152, Lot 339260). The recall was initiated after product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging.
The affected products were distributed nationwide in the United States and internationally to Argentina. The identified hazard is a risk of delay in surgery due to the labeling discrepancy.
Healthcare providers and patients should verify the item and lot numbers on the packaging against the physical product before use. If a mismatch is found, the product should not be used, and Zimmer Biomet should be contacted for further instructions.
The recalled product
- Product
- Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 19
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 (1)
- Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer 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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