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.
FDA device recall Z-1265-2015 · posted 2015-03-12 · Terminated
Recall details
- Recalling firm
- Southern Implants, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 130 units
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2015-01-23
- Date posted
- 2015-03-12
- Date terminated
- 2015-05-20
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSSEOUS DENTAL IMPLANT SYSTEM (K071161) | Southern Implants, Inc. | 2007-11-16 |