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Lower risk Medical device recall · FDA · Published September 25, 2023

Encore Medical: RSP Humeral Socket Insert Risk of Wrong Device for Surgery

Encore Medical recalls RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm (REF: 509-01-436) due to potential wrong device for surgery, causing delays. Check UDI-DI: 00888912144667, Lot: 390P1157.

🇺🇸 FDA recall #Z-0282-2024Medical deviceEncore Medical ›
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Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445
✎ GovInfoNow plain-language explainer

Encore Medical recalls a specific shoulder implant component because two different devices were swapped during packaging. This could cause surgeons to use the wrong device during surgery, leading to delays in treatment. Read more at govinfonow.com/recall/57258-encore-medical-rsp-humeral-socket-insert-risk-of-wrong-device.

Source Summary by GovInfoNow · govinfonow.com/recall/57258-encore-medical-rsp-humeral-socket-insert-risk-of-wrong-device · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0282-2024

Cite this page

“Encore Medical: RSP Humeral Socket Insert Risk of Wrong Device for Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57258-encore-medical-rsp-humeral-socket-insert-risk-of-wrong-device. Based on FDA recall #Z-0282-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0282-2024%22&limit=1).

Encore Medical, LP recalled one size of RSP Humeral Socket Insert orthopedic shoulder implant component on Sept. 25, 2023, according to the FDA. The device was distributed in several states due to a packaging error that could delay surgery.

How to tell if you have it

  • Brand: Encore Medical
  • Product: RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm
  • REF: 509-01-436
  • Lot: 390P1157
  • UDI-DI: 00888912144667

The hazard

Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, according to the FDA. This error could cause a delay in surgery.

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 Tibial Insert packaging discrepancy on Jan. 5, 2026, and incorrect labeling for knee implants on Jan. 15, 2026. Other recent recalls of similar products include Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026) and Howmedica TRIATHLON Hinge Insert Recall (July 30, 2026).

How to tell if you have this one

Check for the product name: RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm. Look for the reference number REF: 509-01-436 and UDI-DI: : 00888912144667, Lot: 390P1157.

  • 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: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Recall numberProduct, codes & lots
Z-0281-2024RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.; UDI-DI: 00190446257585, Lot: 954W1194
Z-0282-2024RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.; UDI-DI: 00888912144667, Lot: 390P1157
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, reference number, and UDI-DI code to confirm if it matches the recalled item.

Where it went and when

Where it was distributed

Distributed in 13 states.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: yesRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Indiana, Kansas, Louisiana, Maine, Minnesota, New Jersey, New York, Ohio, Rhode Island, South Carolina, Texas.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Sep 25, 202312. FDA classified it Class II: Nov 8, 202323. Published in FDA’s Enforcement Report: Nov 15, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-0282-2024 (September 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0282-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA