Zimmer Biomet Recalls LPS-MOB Articular Surface Implants Due to Packaging Issue
Zimmer Biomet is recalling 5,459,583 LPS-MOB Articular Surface Implants because non-highly polished implants may adhere to the LDPE bag.
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, and the hazard involves a packaging defect (adhesion to the bag) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,459,583 units of the LPS-MOB Articular Surface Implant D 9MM. The recall is due to a packaging issue where non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration.
The affected devices were distributed nationwide. The recall number is Z-0324-2020, and the product code is 62067796.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- LPS-MOB ART SURF IMPL D 9MM
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
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)
- 62067796
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 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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