RecallRadar

FDA Device recall Z-1777-2021

REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery

On 2021-06-09 the FDA classified a Class II recall of REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery by Meta C G M Spa, citing sterility issues; single use devices labeled as sterile may not have been adequately sterilized.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1777-2021
ClassificationClass II
Statusterminated
Initiated2021-04-26
Published2021-06-09
Last updated2026-09-13 11:56 UTC
CompanyMeta C G M Spa
DistributionFL, TX

Product

REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

Reason

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1777-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.