Encore Medical Recalls Mislabeled Empowr Knee Baseplate Implants
Encore Medical is recalling seven Empowr Knee System baseplates that were mislabeled as size 6 but are actually size 4.
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: This is a labeling error involving a medical device. While the mislabeling of implant size is a significant quality control failure, the source text does not report any injuries, illnesses, or deaths, and the agency classification is Class II, which typically corresponds to a moderate risk of temporary or medically reversible harm.
Plain-English summary
Encore Medical, Lp is recalling seven units of the Empowr Knee System. These are non-porous proximal tibial baseplate implants used in total knee arthroplasty procedures. The specific issue involves a size 4 baseplate that was incorrectly labeled as a size 6.
The affected lot was laser marked as M6 and marked with the lot number for the size 6 minus lot. Consequently, the product was distributed as a size 6 minus implant. This mislabeling could lead to the use of an incorrectly sized implant during surgery.
The recall covers distribution in the states of Colorado, Illinois, Indiana, Florida, California, and Arizona. Healthcare providers and patients should verify the size of their implants against the correct specifications. If a size 4 baseplate was used where a size 6 was intended, or vice versa, the manufacturer should be contacted.
The recalled product
- Product
- Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
- Manufacturer
- Encore Medical, Lp
- Hazard
- 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 (1)
- 033T1022
Distribution
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