| | Class 2 Device Recall EMPOWR 3D KNEE |  |
| Date Initiated by Firm | February 16, 2026 |
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| Date Posted | July 08, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2700-2026 |
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| Recall Event ID |
98700 |
| 510(K)Number | K143242 |
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| Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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| Product | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty. |
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| Code Information |
Model/Catalog Number: 342-19-703
Lot Code: Lot: 177T1057
GTIN: 00888912167703
Expiration Date: 12/07/2026
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| FEI Number |
1000116912
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Recalling Firm/
Manufacturer |
Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
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| For Additional Information Contact | Sherri Mellingen
952-9136383 |
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Manufacturer Reason
for Recall | Due to packaging discrepancy with incorrect product size mixed up. |
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FDA Determined
Cause 2 | Process change control |
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| Action | On 02/16/2026, the firm emailed an "Urgent: Medical Device Recall" letter to customers informing them that Enovis (Encore Medical L.P) became aware that there is a potential packaging discrepancy with the EMPOWR 3D Knee INS. 342-19-703 (Lot 177T1057), EMPOWR 3D Knee INS, 3R, 19MM, VE, was found within the packaging of a 342-14-711 (Lot 145T1067), EMPOWR 3D Knee INS, 11R, 14MM, VE
Customers are instructed to:
1. Review stock for the products and lot numbers for the items to be returned.
2. Notice needs to be passed on to all those within their organization or to any organization where the product has been transferred.
3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through regional email address, to place a replacement request. An RMA number and shipping label will be provided to return the affected product.
4. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
For any questions, call/text 682-299-9133 or email productsafety@enovis.com |
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| Quantity in Commerce | 4 |
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| Distribution | GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
NE190 Implant Medical Sales, Inc. New York (NY)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
SE180 Joint Medical Solutions, L.L.C. Alabama (AL)
342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1
GL108 Great Lakes Medical Illiniois (IL)
341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2
GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)
341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1
CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1
NW105 Kinetic Medicine South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA)
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2
MA102 ProCore Medical LLC - NC North Carolina (NC)
342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1
Total 11 |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JWH
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