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Use caution Medical device recall · FDA · Published June 2, 2021

Biomet Arcos Hip System Recall: Potential Device Failure Risk

Biomet recalls Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, : Potential device failure leading to surgical intervention. Check lot numbers for affected units.

🇺🇸 FDA recall #Z-2260-2021Medical deviceBiomet ›
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Contact the company

Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

Biomet is recalling a specific hip replacement component due to a risk of device failure that could require additional surgery. This is a serious issue for patients who have this implant. Read more at govinfonow.com/recall/62421-biomet-arcos-hip-system-recall-potential-device-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62421-biomet-arcos-hip-system-recall-potential-device-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2260-2021

Cite this page

“Biomet Arcos Hip System Recall: Potential Device Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62421-biomet-arcos-hip-system-recall-potential-device-failure-risk. Based on FDA recall #Z-2260-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2260-2021%22&limit=1).

The FDA announced on June 2, 2021, that Biomet, Inc. voluntarily recalled the Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM due to potential device failure. The hazard involves chatter in the inner taper fretting corrosion which could lead to surgical intervention.

How to tell if you have it

  • Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM
  • Item Number: 11-301301
  • UPC: 00880304468030
  • Lot Numbers/UDI: 626490 (01)00880304468030(17)310412(10)626490, 679210 (01)00880304468030(17)310418(10)679210

The hazard

According to the FDA, the Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention.

Context

GovInfoNow's records show Biomet, Inc. has 28 other recalls on record since February 28, 2018. Other recent recalls of similar products include Biomet Intramedullary Bone Saw Blade Recall: Sterile Packaging Risk (July 1, 2026), Biomet ZipT: Missing button risk in AC joint implant fix (September 23, 2025), and Biomet Juggerknot Mini Soft Anchors Recall: Wrong Product in Box (September 9, 2025). Other recent recalls of similar products include Howmedica Osteonics Recalls Hip Implant Components Due to Oxidation Risk (July 30, 2026), Howmedica SCORPIO Mobile Bearing PCS Recall: Oxidation Risk in Orthopedic Implants (July 30, 2026), and Howmedica OMNIFIT Series I Acetabular Insert Recall: Oxidation Risk (July 30, 2026).

How to tell if you have this one

Check the lot number on the implant component. Affected units have specific lot numbers: 626490 and 679210 with corresponding UDI numbers.

  • Brand
    Biomet
  • Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
  • Category
    Medical device
FDA recall event · 17 products

All 17 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
    Terminated
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2259-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300; Lot Numbers/UDI : 626440 (01)00880304474611(17)310409(10)626440 626450 (01)00880304474611(17)310322(10)626450 626460 (01)00880304474611(17)310402(10)626460 626890 (01)00880304474611(17)310323(10)626890 678370 (01)00880304474611(17)310419(10)678370 678770 (01)00880304474611(17)310419(10)678770 678800 (01)00880304474611(17)310409(10)678800 695830 (01)00880304474611(17)310412(10)69583088 units
Z-2260-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301; Lot Numbers/UDI : Lot Number UDI Number 626490 (01)00880304468030(17)310412(10)626490 679210 (01)00880304468030(17)310418(10)679210N/A
Z-2261-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302; Lot Numbers/UDI : 626540 (01)00880304474123(17)310423(10)626540 679320 (01)00880304474123(17)310419(10)67932021 units
Z-2262-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310; Lot Numbers/UDI : 004230 (01)00880304473799(17)310412(10)004230 626590 (01)00880304473799(17)310312(10)626590 626600 (01)00880304473799(17)310314(10)626600 678840 (01)00880304473799(17)310305(10)678840 679170 (01)00880304473799(17)310423(10)679170 679180 (01)00880304473799(17)310318(10)679180 880170 (01)00880304473799(17)310409(10)88017081 units
Z-2263-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311; Lot Numbers/UDI : 678930 (01)00880304474086(17)310315(10)678930 880200 (01)00880304474086(17)310427(10)88020022 units
Z-2264-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312; Lot Numbers/UDI : 678950 (01)00880304474093(17)310416(10)678950 880250 (01)00880304474093(17)310422(10)880250 880790 (01)00880304474093(17)310331(10)88079033 units
Z-2265-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314; Lot Numbers/UDI : 934870 (01)00880304474024(17)310419(10)93487010 units
Z-2266-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315; Lot Numbers/UDI : 626180 (01)00880304480551(17)310414(10)6261807 units
Z-2267-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321; Lot Numbers/UDI : 881730 (01)00880304474314(17)310324(10)88173011 units
Z-2268-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322; Lot Numbers/UDI : 678990 (01)00880304473751(17)310407(10)67899011 units
Z-2269-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325; Lot Numbers/UDI : 880850 (01)00880304480575(17)310412(10)88085011 units
Z-2270-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331; Lot Numbers/UDI : 880380 (01)00880304474628(17)310420(10)880380 880870 (01)00880304474628(17)310406(10)880870N/A
Z-2271-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333; Lot Numbers/UDI : 696800 (01)00880304474260(17)310504(10)69680012 units
Z-2272-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335; Lot Numbers/UDI : 881130 (01)00880304480483(17)310418(10)881130N/A
Z-2273-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342; Lot Numbers/UDI : 391390 (01)00880304474208(17)310323(10)39139012 units
Z-2274-2021Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343; Lot Numbers/UDI : 626750 (01)00880304474499(17)310415(10)626750N/A
Z-2275-2021Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354; Lot Numbers/UDI : 880960 (01)00880304474307(17)310504(10)88096012 units
Based on the official FDA remedy

What to do — step by step

  1. Check Your Implant

    Look for the lot number on the implant component to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Jun 2, 202112. FDA classified it Class II: Aug 12, 202123. Published in FDA’s Enforcement Report: Aug 18, 202134. FDA terminated the recall: Jul 6, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-2260-2021 (June 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2260-2021 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.
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