Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are i
FDA device recall Z-0839-2015 · posted 2014-12-22 · Terminated
Recall details
- Recalling firm
- Instradent USA, Inc.
- Reason for recall
- Product not approved for use in the US
- Action taken
- Neodent iniated the recall by telephone and follow-up Recall Notification letter with Confirmation form onAugust 14, 2014, requesting the return of unused product. Customers with questions were instructed to call 978-809-6275. For questions regarding this recall call 855-412-8883, ext 6366.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 13 units
- Distribution
- Nationwide Distribution including AZ, CA, NY, and MA.
- Date initiated
- 2014-08-11
- Date posted
- 2014-12-22
- Date terminated
- 2015-02-06
- Location
- Andover, MA
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