EMPOWR 3D Knee Tibial Insert Recalled for Wrong Product in Package
Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.
What this means for you
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 an FDA Class II recall involving a packaging error where wrong product contents may prevent use of the intended knee implant, resulting in surgical delays. The source reports no injuries or illnesses; the stated consequence is delay rather than harm, supporting a Moderate severity score.
Plain-English summary
Encore Medical, LP, is recalling 9 units of the EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE (Reference: 342-10-706, Lot: 076T1273A) due to a packaging error. Some packages may contain an acetabular system instead of the correct knee tibial insert.
Affected units were distributed nationwide in Indiana, Kansas, California, Florida, New York, Texas, Alabama, and Washington. The packaging error could result in surgical delays while the correct implant is obtained.
Patients and healthcare providers who received affected packages should verify the package contents and contact Encore Medical to arrange replacement with the correct product. Units can be identified by Lot 076T1273A and UDI-DI 00888912167338.
The recalled product
- Product
- EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
- Manufacturer
- Encore Medical, LP
- Hazard
- packaging-error
- product-mix-up
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)
- UDI-DI: 00888912167338. Lot: 076T1273A
Distribution
Distributed nationwide across the United States.
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