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.
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 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
- Affected units
- 27
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
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 →Related recalls
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See all →- HighOral Surgery Devices Recalled for Potential Sterility Failures
FDA (Devices) · 2021-06-09
- HighOral surgery scraper devices recalled due to inadequate sterilization
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- HighOral Surgery Scrapers Recalled Due to Potential Sterility Failure
FDA (Devices) · 2021-06-09
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