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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Similar recalls
- ModerateBiomet 3i Recalls Dental Implant Cover Screws Due to Sealing Defect
FDA (Devices) · 2016-08-24
- ModerateBiomet 3i Recalls Dental Implant Cover Screws Due to Sealing Defects
FDA (Devices) · 2016-08-24
- ModerateBiomet 3i Recalls Dental Implants Due to Unsealed Pouches
FDA (Devices) · 2016-08-24
- ModerateBiomet 3i Recalls Dental Implant Cover Screws Due to Sealing Issues
FDA (Devices) · 2016-08-24
- ModerateBiomet 3i Recalls Titanium Dental Implants Due to Unsealed Pouches
FDA (Devices) · 2016-08-24
- ModerateBiomet 3i Recalls Micromini Flat Implant Cover Screws for Sealing Defects
FDA (Devices) · 2016-08-24