The Recall Desk
HighFDA (Devices)·Z-0417-2026·Announced 2025-11-12

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
Hazard
  • component-mismatch
  • packaging-error
  • implant

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

Distribution scope not specified by the agency.

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