Encore Medical EMPOWR PS Knee e+ Recall: Wrong Implant Packaging
Encore Medical recalls EMPOWR PS Knee e+ inserts (REF 343-19-707) due to incorrect packaging with a different implant model. Affected units may have safety risks from mismatched components.
Lower-risk recall
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Contact the company
What happened, in plain English
Encore Medical is recalling EMPOWR PS Knee e+ inserts (model 343-19-707) because they were mistakenly packaged with a different implant model (343-13-708). This could lead to improper use if the wrong implant is installed. Read more at govinfonow.com/recall/73011-encore-medical-empowr-ps-knee-e-recall-wrong-implant-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/73011-encore-medical-empowr-ps-knee-e-recall-wrong-implant-packaging · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0042-2018
Cite this page
“Encore Medical EMPOWR PS Knee e+ Recall: Wrong Implant Packaging.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73011-encore-medical-empowr-ps-knee-e-recall-wrong-implant-packaging. Based on FDA recall #Z-0042-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0042-2018%22&limit=1).
Why it’s dangerous
The recall involves a packaging error where implant 343-19-707 was shipped with implant 343-13-708. This mismatch could cause improper surgical installation if the wrong implant is used during knee replacement procedures.
Who’s affected
Patients who received the EMPOWR PS Knee e+ insert (model 343-19-707) from Encore Medical are likely affected. Those with surgical implants from this specific model are at risk of incorrect installation.
How to tell if you have this one
Check for the model number 343-19-707 on the packaging or label. The product is a sterile, grey knee insert sold in quantities of 1, size 7, 19mm, with lot number 055U1003.
- Brand
Encore Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0041-2018 | 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 conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.; Lot Number 287U1004 | 48 units |
| Z-0042-2018 | EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, 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 conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.; Lot Number 055U1003 | 46 units |
What to do — step by step
Check Packaging
Verify the model number on the packaging or label to confirm it is 343-19-707.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0042-2018 (September 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0042-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.