Lower riskMedical device recall · FDA · Published August 22, 2023
Encore Medical EMPOWR Hip System Recall: Wrong Parts Risk Surgery Errors
Encore Medical recalls EMPOWR Acetabular System (REF 942-01-40H) due to swapped hip/knee parts in packaging. Surgeons may use incorrect components during surgery. Affected units have specific UDI-DI and lot numbers.
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Encore Medical is recalling its EMPOWR Acetabular System (10° Hooded, HXe+, 40H) because parts were swapped in the packaging. This could lead to surgeons using the wrong components for hip surgery when knee parts were mistakenly included. The recall affects specific units with the listed reference number and expiration date. Read more at govinfonow.com/recall/57460-encore-medical-empowr-hip-system-recall-wrong-parts-risk-surgery.
“Encore Medical EMPOWR Hip System Recall: Wrong Parts Risk Surgery Errors.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57460-encore-medical-empowr-hip-system-recall-wrong-parts-risk-surgery. Based on FDA recall #Z-0103-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0103-2024%22&limit=1).
Encore Medical, LP voluntarily recalled the EMPOWR Acetabular System Liner on August 22, 2023, according to the FDA. The recall was announced because knee insert and acetabular system parts were swapped within inner packs prior to sealing. This error could result in surgeons not having the correct product for surgery.
Knee insert and acetabular system parts were swapped within inner packs prior to the product being sealed within the tray. This could result in surgeons not having the correct product for surgery due to different anatomies (Hip vs Knee).
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Recent similar recalls include the EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (February 16, 2026) and the Encore Medical RSP Humeral Socket Insert Recall (January 15, 2026). Other recent recalls of similar products include the U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026) and the Smith & Nephew BIOSURE HA Screw Recall (November 24, 2025).
How to tell if you have this one
Check for the reference number 942-01-40H on the product label. The units have a specific UDI-DI (00190446309833) and lot number (629Z1114) with an expiration date of March 30, 2028.
Brand
Encore Medical
Category
Medical device
FDA recall event · 2 products
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
Ongoing
Distribution
US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
Recall number
Product, codes & lots
Quantity
Z-0102-2024
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705; UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
Look for the reference number 942-01-40H on the product label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Hawaii, Indiana, Kansas, Louisiana, Minnesota, New Jersey, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0103-2024 (August 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0103-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.