Encore Medical Recalls Foundation Knee System Cut Blocks Due to Marking Error
Encore Medical is recalling 10 units of Foundation Knee System cut blocks because markings are mis-oriented, which could lead to improper surgical cuts.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to improper surgical cuts, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Encore Medical, Lp is recalling 10 units of the Foundation Knee System Non Sterile Femoral A/P Cut Block - Type II (REF 800-01-139). The affected units are from lots 53839799 and 414012 and were distributed to Texas and Georgia.
The recall is due to markings on the distal face of the instruments being mis-oriented by 180 degrees. This includes the Anterior and Posterior indicators, which surgeons use to correctly place the cut block on the femur. Because the cut block is not symmetric, correct orientation is critical for making proper anterior, posterior, and chamfer cuts to fit the femoral implant.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
- Manufacturer
- Encore Medical, Lp
- Affected units
- 10
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)
- Lot 53839799 and 414012
Distribution
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