ClearanceBrief
Recall Z-0926-05 ยท NDP Accessories, Implant, Dental, Endosseous

BioHorizons Implant Systems Inc

The Maestor System 225-312, Profile Abutment for Cement, 5mm

DateJun 23, 2005 (initiated Jun 3, 2005)
StatusTerminated
ReasonThe product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.
Root causeOther
ActionThe domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.
Quantity23 units
DistributionPA, TX, MI, VA and Russia
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.