Zimmer Sidus Head Recall Due to Packaging Adhesion Issue
Zimmer, Inc. is recalling Sidus Heads because the packaging bags adhere to the device surfaces. No units were distributed in the United States.
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. The hazard is a packaging defect (adhesion) rather than a direct biological or mechanical failure causing injury, fitting the criteria for moderate severity involving low-risk contamination or packaging issues.
Plain-English summary
Zimmer, Inc. is recalling Sidus Heads due to a packaging defect. The low density polyethylene (LDPE) bags used to package these implants adhere to the highly polished surface of the devices.
The recall covers part numbers 01.04555.380/525. According to the source text, these products were not distributed in the United States, with a quantity of 0 in the USA. The distribution pattern lists worldwide distribution to various countries, including Argentina, Australia, and Canada, but explicitly notes the lack of US distribution.
Consumers in the United States are not affected by this recall as no units were distributed domestically. Healthcare providers or patients in other countries should contact Zimmer, Inc. for further instructions regarding the packaging issue.
The recalled product
- Product
- Sidus" Head (Not distributed in the United States)
- Manufacturer
- Zimmer, Inc.
- Hazard
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)
- Part Number Range: 01.04555.380/525
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer, 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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