EMPOWR VVC Knee Tibial Insert Recalled for Reversed Box Labeling
Encore Medical recalls EMPOWR VVC Knee Tibial Inserts due to reversed box labeling—large inserts marked as small and vice versa. Surgeons may implant the wrong size if the labeling discrepancy is not identified before 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 a Class II medical device recall involving a labeling error that poses a risk of incorrect surgical implantation. While the potential consequence is significant, no injuries or illnesses have been reported, meeting the rubric criterion for a risk-of-harm product where harm has not yet materialized.
Plain-English summary
Encore Medical, LP is recalling multiple sizes of the EMPOWR VVC Knee Tibial Insert due to labeling errors. Large boxes containing inserts were labeled as small, and small boxes were labeled as large.
If the labeling discrepancy is not identified, a surgeon may implant the incorrect implant size, which could lead to surgical delay. No injuries have been reported at this time.
The recalled products were distributed in Minnesota, Illinois, Indiana, New York, and Florida. Healthcare providers should verify the actual implant size against the box labeling before surgery. Patients who have received one of these implants should contact their healthcare provider if they have concerns.
The recalled product
- Product
- EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, S
- Manufacturer
- Encore Medical, LP
- Hazard
- labeling-error
- implant-size-mismatch
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 (20)
- REF/UDI-DI/Lot: 346-22-706/ 00190446219378/484V1013
- 484V1014
- 484V1015
- 484V1016
- 484V1017
- 484V1018
- 346-22-707/ 00190446219385/485V1001
- 485V1002
- 485V1003
- 485V1004
- 346-22-708/ 00190446219392/486V1005
- 486V1006
- 486V1007
- 486V1008
- 346-22-709/ 00190446219408/487V1001
- 487V1002
- 487V1003
- 487V1004
- 346-22-710/ 00190446219415/488V1003
- 488V1004
Distribution
Distributed in 5 states:
- FL
- IL
- IN
- MN
- NY
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