Zimmer Biomet Recalls Orthopedic Stems Due to Potential Labeling Error
Zimmer Biomet is recalling specific lots of orthopedic stems because they may be mislabeled, potentially extending surgery time by up to 30 minutes.
What this means for you
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 is a minor labeling error that could extend surgery time but does not pose a direct risk of serious injury or death.
Plain-English summary
Zimmer Biomet, Inc. is conducting a lot-specific recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The recall involves the Mini Humeral Stem, which is potentially mislabeled as the Bowed IM Stem lot. The affected product is the Comprehensive Mini Stem, Item No. 113631, with a total of 3 units distributed to accounts in Indiana, Maryland, Missouri, Mississippi, and New Mexico.
The investigation determined that the labeling error could result in a potential extension of surgery time by less than 30 minutes if a replacement is readily available. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and facilities that received these products should contact Zimmer Biomet for further instructions on how to handle the affected units. Consumers are not directly affected by this recall, as the products were distributed to specific medical accounts.
The recalled product
- Product
- Comprehensive Mini Stem, Item No. 113631:
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3
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)
- 568150
Distribution
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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