CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
Neodent Titamax WS Cortical Implant ¿ recalled by Instradent USA
Instradent USA is recalling Neodent Titamax WS Cortical Implant ¿ (Endosseous dental implant) Article Number, distributed nationwide in the US. The recall was initiated on 11 Aug 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0839-2015
- FDA event ID
- 69835
- Recalling firm
- Instradent USA, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Aug 2014
- FDA classified
- 22 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Device type
- Surgical Instruments
Timeline
| 11 Aug 2014 | Recall initiated by company | |
| 22 Dec 2014 | Classified by FDA | +133 days |
| 31 Dec 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product not approved for use in the US
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Where it was distributed
Nationwide Distribution including AZ, CA, NY, and MA.
Questions about this recall
Why was it recalled?
Product not approved for use in the US
Which lots are affected?
Lot Number: 800115427
Where was it sold?
Nationwide Distribution including AZ, CA, NY, and MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Instradent USA
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neodent CM Intraoral Scanbody, Article Number recalled by Instradent USA | Instradent USA | Other | 7 states |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |