Zimmer Biomet Recalls Various Fixation Systems and Accessories
Zimmer Biomet is recalling various fixation systems and accessories 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, which typically indicates a moderate risk. The specific hazard described is a packaging issue where implants may adhere to the bag, which is a functional defect rather than a direct biological or structural failure causing immediate severe injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling various fixation systems and accessories. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products are all items 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 deployment of the devices.
Consumers and healthcare providers should check their inventory for the specific item numbers listed in the official recall notice. If the devices are found, they should stop using them and contact Zimmer Biomet for further instructions on how to proceed.
The recalled product
- Product
- Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014…
- Manufacturer
- Zimmer Biomet, Inc.
- 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 products 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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