Encore Medical Recalls Empowr PS Knee Tibial Inserts Due to Missing Feature
Encore Medical is recalling 24 Empowr PS Knee Tibial Inserts because they are missing the impaction slot feature.
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. The defect is a missing mechanical feature (impaction slot) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a functional defect without immediate harm reports.
Plain-English summary
Encore Medical, Lp is recalling 24 units of the Empowr PS Knee Tibial Insert, Model 343-14-709. These implants are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE and are intended to mate with tibial base implants.
The recall was initiated because the reported inserts were missing the impaction slot feature. The affected units were distributed nationwide to Colorado, New York, and Florida.
The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
- Manufacturer
- Encore Medical, Lp
- Hazard
- Affected units
- 24
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)
- 035U1000
Distribution
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