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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: August 12, 2021
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Affected Products

Product: Arcos 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)695830

Lot Numbers:
Numbers
Product: Arcos 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)679210

Lot Numbers:
Numbers
Number
Product: Arcos 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)679320

Lot Numbers:
Numbers
Product: Arcos 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)880170

Lot Numbers:
Numbers
Product: Arcos 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)880200

Lot Numbers:
Numbers
Product: Arcos 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)880790

Lot Numbers:
Numbers
Product: Arcos 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)934870

Lot Numbers:
Numbers
Product: Arcos 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)626180

Lot Numbers:
Numbers
Product: Arcos 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)881730

Lot Numbers:
Numbers
Product: Arcos 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)678990

Lot Numbers:
Numbers
Product: Arcos 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)880850

Lot Numbers:
Numbers
Product: Arcos 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)880870

Lot Numbers:
Numbers
Product: Arcos 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)696800

Lot Numbers:
Numbers
Product: Arcos 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)881130

Lot Numbers:
Numbers
Product: Arcos 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)391390

Lot Numbers:
Numbers
Product: Arcos 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)626750

Lot Numbers:
Numbers
Product: Arcos 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)880960

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88304
Status: Resolved
Manufacturer: Biomet, Inc.
Manufactured In: United States
Units Affected: 13 products (88 units; 21 units; 81 units; 22 units; 33 units; 10 units; 7 units; 11 units; 11 units; 11 units; 12 units; 12 units; 12 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.