CLASS II ONGOING Device recall · Reported 12 Nov 2025 · FDA Enforcement Report
Inclusive Titanium Screw compatible with: Biomet 3i" Certain recalled
Prismatik Dentalcraft is recalling Inclusive Titanium Screw compatible with: Biomet 3i" Certain, distributed in 18 states. The recall was initiated on 30 Sep 2025 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-0417-2026
- FDA event ID
- 97720
- Recalling firm
- Prismatik Dentalcraft, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2025
- FDA classified
- 3 Nov 2025
- Reported
- 12 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 30 Sep 2025 | Recall initiated by company | |
| 3 Nov 2025 | Classified by FDA | +34 days |
| 12 Nov 2025 | 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
Incorrect titanium screw, packaged with dental implant.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.
CaliforniaColoradoConnecticutFloridaGeorgiaHawaiiKentuckyMassachusettsMarylandMichiganNew HampshireNew JerseyNew YorkPennsylvaniaSouth CarolinaTennesseeVirginiaWashington
Questions about this recall
Why was it recalled?
Incorrect titanium screw, packaged with dental implant.
Which lots are affected?
Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
Where was it sold?
US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.
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.
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