Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Labeling Errors
Encore Medical is recalling five 3DKnee e+ Tibial Inserts because they were shipped with incorrect color-coded labels. The devices were distributed to California and Venezuela.
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 color-coded labels without reporting any injuries, illnesses, or functional defects, fitting the criteria for minor labeling errors.
Plain-English summary
Encore Medical, Lp is recalling five units of the 3DKnee e+ Tibial Insert. The recall was initiated after the U.S. Agent notified the Director of Commercial Logistics that two packages of the inserts contained incorrect color-coded labels. The inserts are used in conjunction with other components of the 3DKnee System.
Upon inspection, it was determined that all eight e+ tibial inserts of the same lot number in Finished Goods, including the two from the agency, were incorrectly labeled. The affected devices are identified by Model/Catalog Number 391-15-708 and Lot/Serial Number 59602230.
The recalled devices were distributed to the state of California in the United States and to the country of Venezuela. Consumers and healthcare providers should stop using these specific inserts and contact Encore Medical for instructions on return or replacement.
The recalled product
- Product
- 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
- Manufacturer
- Encore Medical, Lp
- Hazard
- Affected units
- 5
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)
- Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
Distribution
Distributed in 1 state:
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