The Recall Desk
HighFDA (Devices)·Z-1778-2021·Announced 2021-06-09

Oral surgery scraper devices recalled due to inadequate sterilization

Meta C.G.M. is recalling 150 units of SAFESCRAPER TWIST oral surgery instruments distributed in Texas and Florida due to sterility defects. Single-use sterile devices may not have been adequately sterilized, creating a risk of infection.

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: This is a Class II FDA recall of single-use sterile surgical devices with inadequate sterilization. The failure to properly sterilize instruments intended for oral surgery creates a direct risk of infection. Per the rubric, this represents a risk-of-harm product scenario warranting a High severity score.

Plain-English summary

Meta C.G.M. Spa is recalling 150 units of SAFESCRAPER TWIST (REF 3598, CE 0123), single-use sterile oral surgery instruments. The recall affects devices distributed in Texas and Florida, with lot numbers 26-33118 and 17-19818.

The FDA has identified sterility defects in these devices. Single-use instruments labeled as sterile may not have been adequately sterilized during manufacturing. This defect poses a risk of infection when these instruments are used in oral surgery procedures.

Consumers and healthcare facilities with the affected lot numbers should discontinue use immediately and contact Meta C.G.M. Spa or the FDA for replacement guidance or safe disposal instructions.

The recalled product

Product
REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
Manufacturer
Meta C.G.M. Spa
Category
Medical Device — Surgical Instrument / Oral Surgery
Hazard
  • sterility-defect
  • infection-risk

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)

  • Lot number: 26-33118 and 17-19818

Distribution

Distribution scope not specified by the agency.

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