FDA Device

EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.

Hazard

Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.

What You Should Do

Remedy

Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.

Products

EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
UPC
Lot Number: 560988