RecallRadar

FDA Device recall Z-1776-2021

REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery

On 2021-06-09 the FDA classified a Class II recall of REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, 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-1776-2021
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 3987, SAFESCRAPER CURVE TWIST, CE 0123, 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: 10-10719, 25-31118, 23-27018, 16-17118, 15-17018, 2-01521, 23-26620, 23-26820, 17-17920, 7-06519, 17-19818, 17-19818, and 13-12818

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-1776-2021%22

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