Lower riskMedical device recall · FDA · Published December 18, 2024
Encore Medical EMPOWR 3D Knee Insert Mix-Up May Cause Surgical Delay
Encore Medical recalls two knee tibial inserts that may be mixed up, causing delays in getting the correct surgical product. Affected items have specific model numbers and lot codes.
“Encore Medical EMPOWR 3D Knee Insert Mix-Up May Cause Surgical Delay.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53271-encore-medical-empowr-3d-knee-insert-mix-up-may-cause. Based on FDA recall #Z-0766-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0766-2025%22&limit=1).
The FDA announced on Dec. 18, 2024, that Encore Medical, LP is recalling specific EMPOWR 3D Knee Tibial Inserts due to a packaging mix-up hazard. The agency said the error may cause surgical delays for patients requiring these devices.
How to tell if you have it
Brand: Encore Medical
Product: EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; Lot: 159T1086
Product: EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703; Lot: 137T1086
Quantity: 33 units
Distribution: US Nationwide in VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA
The hazard
According to the FDA, the 5R 16MM knee tibial insert package may contain a 3R 14MM insert and vice versa. This packaging discrepancy may cause surgical delays while medical staff obtain the correct product.
Context
GovInfoNow's records show Encore Medical, LP has issued 43 other recalls since May 31, 2017. Recent brand recalls include an EMPOWR 3D Knee Ins mix-up on Feb. 16, 2026, and an RSP Humeral Socket Insert labeling error on Jan. 15, 2026. Other recent recalls of similar products include Think Surgical TMINI Tracking Arrays (May 8, 2026), U2 Total Knee System (May 20, 2026), and Howmedica TRIATHLON Hinge Insert (July 30, 2026).
How to tell if you have this one
Check the product label for model numbers: 5R 16MM (REF: 342-16-705) or 3R 14MM (REF: 342-14-703). Look for lot codes like 00888912167628 or 00888912167505.
Brand
Encore Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for model numbers on the product label: 5R 16MM (REF: 342-16-705) or 3R 14MM (REF: 342-14-703).
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 VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Illinois, Indiana, Iowa, Maryland, Minnesota, New York, South Carolina, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 14 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-0766-2025 (December 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0766-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.