FDA Medical Device Recalls (openFDA)
Meta C.G.M. Spa: REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
- Recall number
- Z-1776-2021
- Recalling firm
- Meta C.G.M. Spa
- Product
- REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
- Status
- Terminated
- Initiated
- 2021-04-26
- Posted
- not on file
- Terminated
- 2024-09-12
- Reason
- Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
- Root cause
- Vendor change control
- Action
- On April 26, 2021 C.G.M. S.p.A. sent a "Urgent Field Safety Notice" to all affected consignees via email. On May 10, 2021, the firm followed up this communication with an "Urgent: Medical Device Recall" notification to all affected consignee. In addition to informing the customers about the recall, the firm asked consignees to take the following actions: 1. Stop the use of all devices in your possession that have the lot number listed in Attachment 1 2. Circulate this medical device Recall Notice to everyone in your organization who need to be informed; 3. Identify and segregate all items listed in Attachment 01, if still available on the premises. 4. Fill in the Medical device Recall Return REsponse (acknowledgement and receipt form), including the number of received devices, used or sold devices, remaining and segregated devices 5. If the product has been distributed, identify these facilities and immediately submit this notification. 6. Within 20 working days from receiving the official notification, return involved items to the distributor. 7. Within 30 working days from receiving the official notification, the distributor shall return involved items to manufacturer C.g.M. spa divisione medicale META 8. Contact Information for Distributor: C.G.M. spa divisione medicale META Days/Hours Available for call: Monday -Friday, 9:00 AM to 4:30 PM, European Time (UTC/GMT +2 h) Email Address:helpdesk@metahosp.com 9. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch adverse Event Reporting program either online, by regular mail or by fax.
- Quantity
- 8,370 units
- Distribution
- Distribution in US states of Texas and Florida
- Lot, serial or model codes
- Lot 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EMI
- Firm FEI
- 3002693859
- Firm city
- Correggio
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28