Zimmer Biomet Recalls ArComXL Polyethylene Liners Due to Labeling Mismatch
Zimmer Biomet is recalling 36 units of ArComXL polyethylene liners because packaging labels did not match the physical product, 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 is classified as Moderate because it involves a labeling error (packaging mismatch) that poses a risk of surgical delay, which aligns with the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling 36 units of RingLoc ArComXL Highly Crosslinked Polyethylene Liners, ArComXL High Wall +3mm Liners, and ArComXL MaxRom +3mm Liners. The affected items are Size 23, specifically item numbers XL-108323 and XL-108223.
The recall was initiated because product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside. This discrepancy creates a risk of delay in surgery. The products were distributed nationwide in the USA and internationally to Argentina.
Healthcare providers and patients should check their inventory for these specific item and lot numbers. If the packaging does not match the physical product, the items should not be used. Zimmer Biomet is the recalling firm responsible for this action.
The recalled product
- Product
- RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 36
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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