EMPOWER 3D Knee Tibial Insert Recall Due to Packaging Mix-Up
Hip and knee implant boxes from Encore Medical may contain the wrong product, potentially causing surgery delays. The FDA is recalling affected units to prevent unavailability of correct implants.
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: FDA Class II recall with no reported injuries or hospitalizations. The hazard is limited to potential surgical delays due to packaging mix-up; no direct patient safety risk is described in the source.
Plain-English summary
Encore Medical has recalled certain EMPOWER 3D Knee Tibial Inserts (REF: 341-14-708) due to a packaging error where hip liner implants may be found in knee insert boxes and vice versa. The affected batch includes 18 units distributed to medical facilities in Florida, Indiana, Illinois, Kentucky, Arizona, and Texas.
This packaging mix-up could prevent surgeons from accessing the intended knee implant at the time of surgery, potentially delaying surgical procedures. The FDA classified this as a Class II recall.
Healthcare facilities that received this product should verify box contents before using implants in surgical procedures. Contact the manufacturer if you have received affected units (UDI lot 00888912167055/132T1085) to report the issue and arrange replacement.
The recalled product
- Product
- EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
- Manufacturer
- Encore Medical, LP
- Hazard
- packaging-error
- supply-disruption
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/Lot: 00888912167055/132T1085
Distribution
Distributed nationwide across the United States.
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