Thommen Medical, AG Hauptstrasse, 87 Waldenburg Switzerland SPI EASY Abutment. Endosseous dental implant abutment. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SPI EASY Abutment. Endosseous dental implant abutment.
Brand
Thommen Medical, AG Hauptstrasse, 87 Waldenburg Switzerland
Lot Codes / Batch Numbers
#4_03_700 Batch 8007 REF: 1.03.700 LOT: 5121
Products Sold
#4_03_700 Batch 8007 REF: 1.03.700 LOT: 5121
Thommen Medical, AG Hauptstrasse, 87 Waldenburg Switzerland is recalling SPI EASY Abutment. Endosseous dental implant abutment. due to The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.
Recommended Action
Per FDA guidance
Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration.
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