Lower riskMedical device recall · FDA · Published September 9, 2020
Encore Medical EMPOWR Acetabular Cup Recall: Incomplete Machining Risk
Encore Medical recalls EMPOWR Acetabular Cup (Size 54G) due to incomplete machining causing a protruding peg that may lead to improper seating. Affected patients should contact for details.
Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
“Encore Medical EMPOWR Acetabular Cup Recall: Incomplete Machining Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64334-encore-medical-empowr-acetabular-cup-recall-incomplete-machining-risk. Based on FDA recall #Z-0135-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0135-2021%22&limit=1).
The FDA announced on Sept. 9, 2020, that Encore Medical LP voluntarily recalled the EMPOWR Acetabular Cup due to incomplete machining hazards. The agency issued recall number Z-0135-2021 for the specific size and lot code affected.
How to tell if you have it
Brand: Encore Medical
Product: EMPOWR Acetabular Cup, Cluster Hole, 54G
Model Number: 940-02-54G
Lot Number: 801Z1036
Size: 54G (54 mm Dia.)
Alpha Code: G
The hazard
According to the FDA, incomplete machining left a small peg remnant on the top of the dome that protrudes above the surrounding porous coating. This defect causes the cup not to seat properly.
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Recent brand recalls include a Feb. 16, 2026 packaging mix-up for the EMPOWR 3D Knee Ins 11L 14MM VE and a Jan. 15, 2026 incorrect labeling hazard for the RSP Humeral Socket Insert. Other recent recalls of similar products include a Dec. 4, 2025 Merit Medical Custom Manifold Kit recall and a July 30, 2026 Howmedica TRIATHLON Hinge Insert recall.
How to tell if you have this one
Check for the model number 940-02-54G and lot number 801Z1036 on the product. The product is used for hip replacement surgery.
Brand
Encore Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Encore Medical for specific instructions on handling the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Minnesota, Mississippi, New York, South Carolina, Tennessee, Virginia.
Recall timeline
FDA published this recall 49 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-0135-2021 (September 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0135-2021 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.