Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error
Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging/labeling error without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Encore Medical, Lp is recalling 48 units of EMPOWR PS KNEE(TM) e+ inserts, reference 343-13-708, size 8, 13mm, lot number 287U1004. The recall was initiated because it was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
The affected products are sterile, sky blue, posterior stabilized knee inserts made from ultra high molecular weight polyethylene infused with alpha-tocopherol. The distribution pattern for these units was US Nationwide Distribution.
Healthcare providers and facilities should stop using the affected lot and contact Encore Medical for instructions on returning the product. This recall addresses a packaging and labeling discrepancy rather than a defect in the implant material itself.
The recalled product
- Product
- EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
- Manufacturer
- Encore Medical, Lp
- Affected units
- 48
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 Number 287U1004
Distribution
Distributed nationwide across the United States.
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Encore Medical, Lp
See all →- ModerateEMPOWR 3D Knee surgical device recalled due to packaging discrepancy
FDA (Devices) · 2026-07-15
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereKnee and Humeral Socket Implants Recalled for Incorrect Labeling
FDA (Devices) · 2026-03-04
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02