Recall Z-1265-2015 ยท DZE Implant, Endosseous, Root-Form
Southern Implants, Inc
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.
| Date | Mar 12, 2015 (initiated Jan 23, 2015) |
| Status | Terminated |
| Reason | Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa. |
| Root cause | Mixed-up of materials/components |
| Action | A customer notification letter dated 1/23/15 was sent to customers to inform them that Southern Implant is recalling the MAX-TL 9.0x7.0mm Implant because it may contain a Z-MAX9-7 Implant, 9mm diameter, 7mm length. Customers are instructed to return the fax back form and to contact customer relations depart at (866) 902-9272. |
| Quantity | 130 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Southern Implants, Inc., Nov 16, 2007 |