Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Expired Labeling
Encore Medical is recalling 7 units of 3DKnee e+ Tibial Inserts because shelf life labeling was incorrect and the components were expired.
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, but the source text identifies the issue as incorrect shelf life labeling and expired components without reporting any specific injuries, illnesses, or structural failures, fitting the criteria for a moderate severity labeling/quality control issue.
Plain-English summary
Encore Medical, Lp is recalling 7 units of 3DKnee e+ Tibial Inserts, Model Number 392-09-706, Lot Number 59602519. The specific product affected is the 9 mm, Size 6, Right insert made of highly cross-linked vitamin E polyethylene (HXLPE-VE).
The recall was initiated because the shelf life labeling for these specific lots was found to be incorrect, and the components were determined to be expired. The product was distributed worldwide, including Venezuela.
Consumers and healthcare providers should stop using the affected inserts and contact Encore Medical, Lp for further instructions or a replacement.
The recalled product
- Product
- 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This…
- Manufacturer
- Encore Medical, Lp
- Affected units
- 7
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 (2)
- Model Number 392-09-706
- Lot Number 59602519
Distribution
Distribution scope not specified by the agency.
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