EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
Lot Codes / Batch Numbers
Lot Number: 560988
Products Sold
Lot Number: 560988
A medical device manufacturer is recalling EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected due to Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026