Reported Mar 8, 2023 · Ongoing
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF:…
Encore Medical, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Encore Medical, LP · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
14 products · 57 lot codes
346-22-706EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM
- UDI-DI
00190446219378
6 recalled lot codes
484V1013484V1014484V1015484V1016484V1017484V1018
346-22-707EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM
- UDI-DI
00190446219385
4 recalled lot codes
485V1001485V1002485V1003485V1004
346-22-708EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM
- UDI-DI
00190446219392
4 recalled lot codes
486V1005486V1006486V1007486V1008
346-22-709EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM
- UDI-DI
00190446219408
4 recalled lot codes
487V1001487V1002487V1003487V1004
Page 1 of 4
- Amount recalled
- 216
Where it was sold
Why it was recalled
Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
This product could cause temporary or reversible health problems — stop using it.
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