Dental implant screws recalled because the wrong screw was packaged
Prismatik Dentalcraft is recalling 208 Inclusive Titanium Screws because an incorrect titanium screw was packaged with the dental implant.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a mismatched component supplied with an implant can be placed in the patient, and no injuries are reported.
Plain-English summary
The Inclusive Titanium Screw compatible with Biomet 3i Certain 3.4/4.1/5.0/6.0 mm implants, catalog number 70-1047-COM0117, from Prismatik Dentalcraft, is being recalled.
The recall follows an incorrect titanium screw being packaged with the dental implant.
The recall covers 208 units, distributed in California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky and Maryland among other states. The FDA has classified the action as Class II.
The enforcement record describes the packaging error and reports no injuries. Because the screw is placed in the patient, dental practices holding affected stock should quarantine it and follow the firm's instructions.
The recalled product
- Product
- Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
- Manufacturer
- Prismatik Dentalcraft, Inc.
- Category
- Medical Device — Dental implant
- Affected units
- 208
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 6271089
Distribution
Related recalls
Same manufacturer · Prismatik Dentalcraft, Inc.
See all →- ModerateSilent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance
FDA (Devices) · 2026-07-29
- ModerateGlidewell HT Implant Twist Drill recalled due to packaging mix-up
FDA (Devices) · 2025-06-04
- ModeratePrismatik Recalls BruxZir Shaded Dental Restorations Due to Quarantine Failure
FDA (Devices) · 2016-10-05
Same hazard · component mismatch
See all →- ModerateMAMMOMAT Revelation systems recalled because operator tables shipped with bus-installation kits
FDA (Devices) · 2025-12-10
- ModerateMAMMOMAT Inspiration systems recalled because operator tables shipped with bus-installation kits
FDA (Devices) · 2025-12-10
- ModerateMAMMOMAT Fusion system recalled because an operator table shipped with a bus-installation kit
FDA (Devices) · 2025-12-10
- HighSize G hip bearings recalled over commingled implant sizes in packaging
FDA (Devices) · 2025-11-12
- HighHip bearings recalled because size F packages contain size G implants
FDA (Devices) · 2025-11-12