Z-1646-2021Class II

10 Gauge Single Cement Delivery 4 Fillers 4 Syringes, Code Intvm-Scdk

Name: Z-1646-2021 10 Gauge Single Cement Delivery 4 Fillers 4 Syringes, Code Intvm-Scdk
Creator: Biopsybell S.r.l.
Published: 2021-03-22
License: https://open.fda.gov/license/

Biopsybell S.r.l. / initiated 2021-03-22 / Terminated / root cause: supplier

FDA source

BIOPSYBELL S.R.L. began a recall of 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK on 2021-03-22. FDA classified it as Class II and gives the reason as "Products labeled as sterile were distributed, but may not have been 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-1646-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-22
Posted: 2021-05-19
Terminated: 2026-02-17
Recalling firm: Biopsybell S.r.l.
Product: 10 Gauge Single Cement Delivery 4 Fillers 4 Syringes, Code Intvm-Scdk
Product code: LOD Bone Cement
Reason for recall: Products labeled as sterile were distributed, but may not have been sterilized.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The firm notified two consignees with the preliminary information by email on 03/22/2021 and followed with the official notice with the complete information on 04/08/2021 to all consignees. The letter requested that the consignee cease using the affected product and contact Biopsybell or a Biopsybell representative for product return/disposal and related replacement. Distributors were directed to identify those who received the product and notify them.
Quantity in commerce: 305 units
Distribution: US Nationwide distribution in the states MS and KY.
Product codes and lots: LOT: 2002439, 20051290, 20061420, 20081943

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1646-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1631-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1632-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1633-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1634-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1635-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1636-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1637-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1638-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1639-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1640-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1641-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1642-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1643-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1644-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1645-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1646-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1647-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1648-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19
Z-1649-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-19

Product code LOD

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)