Agency classClass IIOur severity:High FDA (Devices)·Z-1776-2021·Announced 2021-06-09

Oral Surgery Scrapers Recalled Due to Potential Sterility Failure

Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scrapers distributed in Texas and Florida due to sterility concerns. The single-use sterile devices may not have been adequately sterilized.

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: This is an FDA Class II recall for sterility failure in single-use surgical devices. Although no illnesses or injuries have been reported, the failure to achieve adequate sterilization on devices intended for oral surgery creates a risk of infection.

Plain-English summary

Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scraper due to potential sterility failures. Single-use devices labeled as sterile may not have been adequately sterilized during manufacturing.

The recall affects 8,370 units distributed in Texas and Florida. The affected lot numbers are: 10-10719, 25-31118, 23-27018, 16-17118, 15-17018, 2-01521, 23-26620, 23-26820, 17-17920, 7-06519, 17-19818, and 13-12818.

Healthcare facilities and practitioners should identify and discontinue use of affected units. If any of these devices have been used, consult with your healthcare provider regarding any potential exposure concerns.

The recalled product

Product: REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Manufacturer: Meta C.G.M. Spa
Category: Medical Device — Surgical Instruments
Hazard: sterility-failure
Affected units: 8,370

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 (12)

Lot number: 10-10719
25-31118
23-27018
16-17118
15-17018
2-01521
23-26620
23-26820
17-17920
7-06519
17-19818
and 13-12818

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 recalled by Meta C.G.M. Spa under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Meta C.G.M. Spa

See all →

High
Oral Surgery Devices Recalled for Potential Sterility Failures
FDA (Devices) · 2021-06-09
High
Oral surgery scraper devices recalled due to inadequate sterilization
FDA (Devices) · 2021-06-09
High
Oral surgery scrapers recalled due to possible inadequate sterilization
FDA (Devices) · 2021-06-09

Same hazard · sterility failure