Zimmer Segmental System Polyethylene Inserts Recalled for Surgical Technique Update
Zimmer, Inc. is recalling knee replacement polyethylene inserts to update surgical instructions regarding excessive loading risks.
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 involves an update to surgical instructions to address a risk of excessive loading, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported serious injury.
Plain-English summary
Zimmer, Inc. is recalling Zimmer Segmental Systems Polyethylene Inserts, Size C, used in knee replacement procedures. The recall involves 5,305 distribution events with worldwide distribution, including the USA, Germany, and other EU countries. The specific part number is 00-5850-013-95.
The recall is initiated after the evaluation of 13 complaints, representing a 0.4% rate, regarding hyper-extension of the Zimmer Segmental System. The company is updating the related surgical technique and instructions for use to provide additional guidance on patient conditions that may place excessive loading on the polyethylene insert.
Healthcare providers and patients should refer to the updated instructions for use to ensure proper surgical technique and patient selection to minimize the risk of excessive loading on the device.
The recalled product
- Product
- Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 5,305
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 numbers 00-5850-013-95
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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