Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.
“Encore Medical EMPOWR Knee Drills: Incorrect Size Risk of Implant Loosening.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58845-encore-medical-empowr-knee-drills-incorrect-size-risk-of-implant. Based on FDA recall #Z-1384-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1384-2023%22&limit=1).
The FDA announced on Feb. 28, 2023, that Encore Medical, LP is recalling EMPOWR Porous Knee Patella Over Drills and EMPOWR Knee Patella Drills due to incorrect diameter markings. The agency said the error poses a risk of implant loosening, improper fitting, or fractured bone during surgery.
The recall involves patella drills marked with an incorrect diameter size of 5.6mm instead of the required 5.4mm, and porous patella overdrills marked with 5.4mm instead of 5.6mm. According to the FDA, using the incorrect drill during surgery risks implant loosening, improper fitting, or fractured bone.
Context
GovInfoNow's records show Encore Medical, LP has issued 43 other recalls since May 31, 2017. Recent brand actions include a Feb. 16, 2026, product mix-up recall for EMPOWR 3D Knee Ins and a Jan. 15, 2026, labeling hazard recall for RSP Humeral Socket Inserts. Other recent recalls of similar products include U2 Total Knee System: Incorrect Implant Orientation Risk (March 19, 2026), Think Surgical TMINI Tracking Arrays: Risk of Misalignment Due to Loose Knob (May 8, 2026), and U2 Total Knee System: Risk of Improper Assembly Due to Manufacturing Defect (May 20, 2026).
How to tell if you have this one
Check for the model numbers 802-05-104 or 802-05-108 on the drill. The recall includes specific serial numbers and lot codes listed in the product description.
Brand
Encore Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Drill Model
Verify the drill model number is 802-05-104 or 802-05-108 to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “US: TX, IN, MD, CA, KS, AL, HI, WA” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-1384-2023 (February 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1384-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.