Zimmer Biomet Recalls Coorad Morrey Total Elbow Implants
Zimmer Biomet is recalling Coorad Morrey Total Elbow implants because non-highly polished components may adhere to the packaging 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 source text describes a packaging-related issue (adherence to the bag) without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Coorad Morrey Total Elbow implant system. The recall covers 5,459,583 total devices, including specific item numbers such as 32810502501 and 32855510844. The affected products were distributed nationwide and were manufactured prior to January 2014.
The recall is being conducted because non-highly polished implants may adhere to the LDPE bag used in the previous packaging configuration. This issue is associated with the specific packaging method used for these devices.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or removal of the affected implants.
The recalled product
- Product
- Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844
- 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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