Zimmer Biomet Recalls CLS Brevius Stem Kinectiv Hip Prostheses
Zimmer Biomet is recalling CLS Brevius Stem Kinectiv hip prostheses because non-highly polished implants may adhere to the packaging bag.
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. The hazard involves a packaging issue where implants may adhere to the bag, which is a potential risk but does not involve reported injuries or high-risk pathogens, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Zimmer Biomet, Inc. is recalling the CLS Brevius Stem Kinectiv hip prosthesis in various sizes. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products are all units manufactured prior to January 2014.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially affect the handling or installation of the device.
Healthcare providers and patients who have received or are considering this specific hip prosthesis should contact Zimmer Biomet for further instructions. The company is responsible for managing the recall and providing guidance on next steps.
The recalled product
- Product
- CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200
- 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)
- All product manufactured prior to January 2014.
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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