FDA Recalls EMPOWR 3D Knee Tibial Inserts Due to Packaging Discrepancy
Encore Medical is recalling 20 EMPOWR 3D knee tibial inserts due to incorrect products being packaged together. Using the wrong implant could require revision surgery.
What this means for you
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: This is an FDA Class II medical device recall involving a risk of incorrect implant placement, which could necessitate revision surgery. However, no injuries or illnesses have been reported in the source material, placing this in the 'High' category per the rubric guidance on risk-of-harm products without reported injury.
Plain-English summary
Encore Medical, LP is recalling 20 units of the EMPOWR 3D knee tibial insert (model 341-12-711, lot 115T1077) due to a packaging error.
The recall was initiated because incorrect tibial inserts may be packaged together in the same containers, potentially causing healthcare providers to select and implant the wrong device during knee replacement surgery.
If an incorrect implant is implanted, a patient may require revision surgery to remove and replace the device with the correct one.
The recalled devices were distributed to healthcare facilities in Arizona, Iowa, Idaho, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Utah, Virginia, and Washington. Healthcare providers with these devices should contact Encore Medical, LP, or their hospital's supply chain team immediately.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty p
- Manufacturer
- Encore Medical, LP
- Hazard
- packaging-error
- device-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)
- Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077
Distribution
Distributed in 18 states:
- AZ
- IA
- ID
- IL
- IN
- LA
- MI
- MO
- MS
- NE
- NY
- OK
- OR
- PR
- SD
- UT
- VA
- WA
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