Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side
Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an implant labeled with the wrong size or side could be selected in surgery, and no injuries are reported.
Plain-English summary
The EMPOWR 3D Knee Tibial Insert - E-PLUS, product name EMPOWR 3D KNEE INS, 4L 16MM, VE, model and catalog number 341-16-704, is being recalled. The affected implants carry GTIN 00888912167116 and lot number 148T1057. The recall covers 18 implants distributed in Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, New York, Tennessee and Texas.
The recall was issued because the knee implants contain incorrect labeling, with the size and/or side stated incorrectly. Enovis knee devices are intended for patients who are candidates for knee arthroplasty. The FDA classified the action as Class II.
Hospitals and surgical centres holding this catalog number should check the lot number above, quarantine affected stock and follow the manufacturer's instructions for return.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
- Manufacturer
- Encore Medical, LP
- Affected units
- 18
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: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
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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