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.
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 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
- Affected units
- 150
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
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 scrapers recalled due to possible inadequate sterilization
FDA (Devices) · 2021-06-09
- HighOral Surgery Scrapers Recalled Due to Potential Sterility Failure
FDA (Devices) · 2021-06-09
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