The Recall Desk
HighFDA (Devices)·Z-1777-2021·Announced 2021-06-09

Oral Surgery Devices Recalled for Potential Sterility Failures

Meta C.G.M. Spa is recalling MICROSS oral surgery devices due to sterility concerns. Units labeled as sterile 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 of surgical devices with inadequate sterilization, a high-risk hazard for patient infection. No illnesses or injuries are reported in the source text, qualifying this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Meta C.G.M. Spa is recalling 1,692 units of REF 4049 MICROSS oral surgery devices (CE0123, sterile, ethylene oxide sterilized).

The devices are being recalled because units labeled as sterile may not have been adequately sterilized. Inadequate sterilization of single-use surgical instruments creates a risk of patient infection.

The recalled devices were distributed to Texas and Florida. The affected lot numbers are 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, and 26-33118.

Patients and healthcare providers who have devices from these affected lot numbers should contact Meta C.G.M. Spa or their healthcare provider for guidance on appropriate action.

The recalled product

Product
REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Manufacturer
Meta C.G.M. Spa
Category
Medical Device — Surgical Instruments
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 (8)

  • Lot number: 2-01121
  • 23-28920
  • 21-26520
  • 18-24819
  • 24-29118
  • 21-24818
  • 13-12818
  • 26-33118

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category