Reported Aug 24, 2016 · Terminated
Bellatek Encode Healing Abutment Dental implants
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?
- Bellatek Encode Healing Abutment Dental implants
- Lot codes and dates
- Items
EHA343EHA344EHA346EHA348EHA353EHA354EHA356EHA358EHA443EHA444EHA446EHA448EHA453EHA454EHA456EHA458EHA463EHA464EHA466EHA468EHA473EHA474EHA476EHA478EHA553EHA554EHA556EHA558EHA563EHA564EHA566EHA568EHA573EHA574EHA576. EHA578EHA663EHA664EHA666EHA668EHA673EHA674EHA676 and EHA678
- Items
- Amount recalled
- 1,648,273 devices (all products subject to this recall).
This recall covers 119 products
The agency filed one notice per product. You are reading one of them; the other 118 are below.
106 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Pouches may not have been sealed during packing.
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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