Reported Oct 14, 2020 · Terminated
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Biomet 3i, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet 3i, LLC · 4555 Riverside Dr · Palm Beach Gardens, FL · 33410-4200
Is this the product you have?
- CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM
- Reference NumberIEDAT4
- Lot codes and dates
- Lot Numbers
8560281-18560299-18561332-38561476-18563315-18564057-18564060-38564060-48564064-18564524-18564524-28565357-18565414-38566637-18566637-28566648-18566969-28567559-18567578-18568041-18568705-18568819-18569841-78569987-18570625-18570737-18571824-18571843-18571850-18571866-18571887-48571887-58572228-18572238-18572238-2
- 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
- Amount recalled
- 35 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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