EMPOWR 3D knee 10mm tibial inserts were packaged with wrong implant
EMPOWR 3D Knee Tibial Insert E-PLUS units, catalog number 341-10-711, are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units affected.
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: Risk-of-harm product: the manufacturer states the wrong implant may be selected and that revision surgery could result, with no such surgery reported in the source.
Plain-English summary
The EMPOWR 3D Knee Tibial Insert - E-PLUS, 11L 10 mm, catalog number 341-10-711, GTIN 00888912166881, is being recalled. The action covers 20 units from lot 071T1084.
According to the manufacturer, there is a packaging discrepancy with the incorrect tibial inserts or implants being packaged. The manufacturer states that use of this product may result in the incorrect product being selected, which could result in a revision surgery if used. The FDA classified the action as Class II. The source does not report any revision surgery having occurred.
Distribution was in Arizona, Iowa, Idaho, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York and Oklahoma among other states. The implants are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, GTIN and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 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
- Affected units
- 20
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: 341-10-711 GTIN: 00888912166881 Lot\s: 071T1084
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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