Use cautionMedical device recall · FDA · Published August 7, 2020
Encore Medical RSP Humerus Socket Insert Recall: Size Mismatch Risk
Encore Medical recalls RSP Standard Humerus Socket Insert (44mm) due to possible size mismatch with patient labels, risking incorrect implant and surgery complications.
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
“Encore Medical RSP Humerus Socket Insert Recall: Size Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64512-encore-medical-rsp-humerus-socket-insert-recall-size-mismatch-risk. Based on FDA recall #Z-3021-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3021-2020%22&limit=1).
The FDA announced on August 7, 2020, that Encore Medical, LP voluntarily recalled the RSP Standard HUMERAL SOCKET INSERT due to mislabeling risks. The agency stated the hazard involves potential implantation of incorrect sizes.
How to tell if you have it
Brand: Encore Medical
Product: RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus
Part No.: 509-00-044
Lot: 380P1009A
UDI: 00888912144568
The hazard
The product may be mislabeled with a size etched onto the device that differs from the patient sticker label. This discrepancy risks the surgeon implanting the incorrect size, leading to significant physical impairment, discomfort, disruption of treatment, or patient dislocation requiring revision surgery.
Context
GovInfoNow's records show Encore Medical, LP has issued 43 other recalls since May 31, 2017. Recent brand recalls include the February 16, 2026 EMPOWR 3D Knee Ins 11L 14MM VE packaging mix-up and the January 15, 2026 RSP Humeral Socket Insert incorrect labeling hazard. Other recent recalls of similar products include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Howmedica TRIATHLON Hinge Insert Recall (July 30, 2026), and the ConMed Suture Anchor Recall (July 14, 2026).
How to tell if you have this one
Check for the part number 509-00-044 on the insert. The lot number 380P1009A and UDI 00888912144568 are also associated with this recall.
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
Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA
Recall number
Product, codes & lots
Quantity
Z-3021-2020
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044; Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
15 units
Z-3022-2020
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440; Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, UDI: 00888912144599
37 units
Based on the official FDA remedy
What to do — step by step
Check Implant Size
Compare the size marked on the insert with the patient label to ensure they match.
Where it went and when
Where it was distributed
Distributed in 12 states.
Listed by the agency
Not listed
FDA distribution: “Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Indiana, Kansas, Minnesota, New York, Oklahoma, Pennsylvania, Rhode Island, Virginia, Washington.
Recall timeline
FDA published this recall 2 months 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-3021-2020 (August 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3021-2020 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.