The Recall Desk
HighFDA (Devices)·Z-1779-2021·Announced 2021-06-09

Oral surgery scrapers recalled due to possible inadequate sterilization

Meta C.G.M. Spa recalls 27 units of REF 4890 SMARTSCRAPER oral surgery instruments distributed in Texas and Florida. The sterile-labeled devices may not have been adequately sterilized.

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 an FDA Class II recall with no reported illnesses or injuries. However, inadequate sterilization of single-use surgical instruments used in invasive oral surgery presents a significant risk of serious infection. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Meta C.G.M. Spa is recalling 27 units of the REF 4890 SMARTSCRAPER CE0123 sterile oral surgery instrument due to potential sterilization failures. The affected devices were distributed to locations in Texas and Florida. The lot number involved is 1-35319.

The recalled devices are labeled as sterile and single-use for oral surgery procedures. However, they may not have been adequately sterilized, creating a risk of infection if used in invasive dental procedures.

Patients or healthcare providers who received these devices should cease use immediately and contact Meta C.G.M. Spa for further instructions. Individuals who may have been treated with these instruments should consult their healthcare provider if they experience signs of infection.

The recalled product

Product
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Manufacturer
Meta C.G.M. Spa
Category
Medical Device — Surgical Instruments / Oral Surgery
Hazard
  • inadequate-sterilization
  • 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: 1-35319

Distribution

Distribution scope not specified by the agency.

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