Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Device

Biomet 3i, LLC: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

Agency Publication Date: October 8, 2020
Share:
Sign in to monitor this recall

Affected Products

Product: BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4

Lot Numbers: 8570638-1 UDI: (01)00844868030911(10)8570638-1; 8572781-3 UDI: (01)00844868030911(10)8572781-3

Lot Numbers:
Numbers
Product: BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ

Reference Number: 3DPMSER Lot Numbers: 8560249-1 8564285-1 8570989-1 Reference Number: 3DPMSERQ Lot Numbers: 8561588-1 8561591-1 8569150-1 8570607-1

Lot Numbers:
Numbers
Numbers
Product: CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

Lot Numbers: 8563336-1 8563892-1 8563910-1 8565718-2 8571887-1 8571887-2 8571887-3 8572668-1 8572668-2 UDI: (01)00844868031147(10)8563336-1 (01)00844868031147(10)8563892-1 (01)00844868031147(10)8563910-1 (01)00844868031147(10)8565718-2 (01)00844868031147(10)8571887-1 (01)00844868031147(10)8571887-2 (01)00844868031147(10)8571887-3 (01)00844868031147(10)8572668-1 (01)00844868031147(10)8572668-2

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5

Lot Numbers: 8560155-1 8565718-1 8565734-1 8569780-1 UDI: (01)00844868031154(10)8560155-1 (01)00844868031154(10)8565718-1 (01)00844868031154(10)8565734-1 (01)00844868031154(10)8569780-1

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4

Lot Numbers: 8560281-1 8560299-1 8561332-3 8561476-1 8563315-1 8564057-1 8564060-3 8564060-4 8564064-1 8564524-1 8564524-2 8565357-1 8565414-3 8566637-1 8566637-2 8566648-1 8566969-2 8567559-1 8567578-1 8568041-1 8568705-1 8568819-1 8569841-7 8569987-1 8570625-1 8570737-1 8571824-1 8571843-1 8571850-1 8571866-1 8571887-4 8571887-5 8572228-1 8572238-1 8572238-2 UDI: (01)00844868031185(10)8560281-1 (01)00844868031185(10)8560299-1 (01)00844868031185(10)8561332-3 (01)00844868031185(10)8561476-1 (01)00844868031185(10)8563315-1 (01)00844868031185(10)8564057-1 (01)00844868031185(10)8564060-3 (01)00844868031185(10)8564060-4 (01)00844868031185(10)8564064-1 (01)00844868031185(10)8564524-1 (01)00844868031185(10)8564524-2 (01)00844868031185(10)8565357-1 (01)00844868031185(10)8565414-3 (01)00844868031185(10)8566637-1 (01)00844868031185(10)8566637-2 (01)00844868031185(10)8566648-1 (01)00844868031185(10)8566969-2 (01)00844868031185(10)8567559-1 (01)00844868031185(10)8567578-1 (01)00844868031185(10)8568041-1 (01)00844868031185(10)8568705-1 (01)00844868031185(10)8568819-1 (01)00844868031185(10)8569841-7 (01)00844868031185(10)8569987-1 (01)00844868031185(10)8570625-1 (01)00844868031185(10)8570737-1 (01)00844868031185(10)8571824-1 (01)00844868031185(10)8571843-1 (01)00844868031185(10)8571850-1 (01)00844868031185(10)8571866-1 (01)00844868031185(10)8571887-4 (01)00844868031185(10)8571887-5 (01)00844868031185(10)8572228-1 (01)00844868031185(10)8572238-1 01)00844868031185(10)8572238-2

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5

Lot Numbers: 8561074-1 8563880-1 8564060-1 8565449-1 8565945-1 8566616-1 8568052-1 8568808-1 8569206-1 8571880-1 UDI: (01)00844868031192(10)8561074-1 (01)00844868031192(10)8563880-1 (01)00844868031192(10)8564060-1 (01)00844868031192(10)8565449-1 (01)00844868031192(10)8565945-1 (01)00844868031192(10)8566616-1 (01)00844868031192(10)8568052-1 (01)00844868031192(10)8568808-1 (01)00844868031192(10)8569206-1 (01)00844868031192(10)8571880-1

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6

Lot Number: 8562282-1 UDI: (01)00844868031208(10)8562282-1

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86402
Status: Resolved
Manufacturer: Biomet 3i, LLC
Manufactured In: United States
Units Affected: 7 products (7 stand alone units; 2 units; 9 units; 4 units; 35 units; 10 units; 1 unit)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.