Encore Medical Recalls Foundation Modular Femoral Stem for Lack of Clearance
Encore Medical is recalling 12 units of the Foundation Modular Femoral Stem because the device lacks FDA clearance.
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 the source text identifies the issue as a lack of FDA clearance and a labeling complaint, with no reported injuries or illnesses.
Plain-English summary
Encore Medical, Lp is recalling 12 units of the Foundation Modular Femoral Stem, part number 220-10-110. This product is a knee prosthesis component used in the Foundation Revision Knee total knee system, which is indicated for knee joint replacement in patients suffering from pain and dysfunction.
The recall was initiated after the company received a product complaint regarding the device's labeling. Upon investigation, it was determined that this specific device does not have FDA clearance.
The affected units were distributed in the United States to Arizona, Missouri, Mississippi, New York, Oklahoma, and Utah, as well as internationally to Japan. The recall covers all lots, specifically identified as 866A1011 and 866A1022.
The recalled product
- Product
- Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
- Manufacturer
- Encore Medical, Lp
- Affected units
- 12
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)
- All. Lots-866A1011
- 866A1022
Distribution
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