Zimmer Biomet Recalls Trabecular Metal Reverse Shoulder System Implants
Zimmer Biomet is recalling Trabecular Metal Reverse Shoulder System implants because non-highly polished components 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, and the hazard involves potential adherence to packaging, which is a moderate risk without reported injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Trabecular Metal Reverse Shoulder System. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products include various item numbers and were all manufactured prior to January 2014.
The reason for the recall is that non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially affect the handling or integrity of the devices during storage or preparation.
Healthcare providers and patients who have received these implants should contact Zimmer Biomet for further instructions. The company is responsible for managing the recall and providing guidance on the next steps for affected individuals.
The recalled product
- Product
- Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 0043421
- 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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