Z-1777-2021Class II

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

Name: Z-1777-2021 REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery
Creator: Meta C.G.M. Spa
Published: 2021-04-26
License: https://open.fda.gov/license/

Meta C.G.M. SpA / initiated 2021-04-26 / Terminated / root cause: supplier

FDA source

Meta C.G.M. Spa began a recall of REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery on 2021-04-26. FDA classified it as Class II and gives the reason as "Sterility issues; single use devices labeled as sterile may not have been adequately sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1777-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-26
Posted: 2021-06-02
Terminated: 2024-09-12
Recalling firm: Meta C.G.M. SpA
Product: REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Product code: EMI File, Bone, Surgical
Reason for recall: Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Root cause tag: supplier
FDA 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:[email protected] 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 in commerce: 1,692
Distribution: Distribution in US states of Texas and Florida
Product codes and lots: Lot number: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-33118

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1777-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1776-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-02
Z-1777-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-02
Z-1778-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-02
Z-1779-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-02

Product code EMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)