Exact FDA event identifier

Event 87696

19 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 22, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: BIOPSYBELL S.R.L.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

19 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 19

BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system

Z-1631-2021

Recall number: Z-1631-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

BATCH: 19123253

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 2 of 19

RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US

Z-1632-2021

Recall number: Z-1632-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

BATCH: 20061305

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 3 of 19

BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US

Z-1633-2021

Recall number: Z-1633-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

BATCH: 20061307

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 4 of 19

BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111

Z-1634-2021

Recall number: Z-1634-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

BATCH Numbers: 20061439

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 5 of 19

CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051

Z-1635-2021

Recall number: Z-1635-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

BATCH:2003721

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 6 of 19

EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS

Z-1636-2021

Recall number: Z-1636-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

BATCH:2003721

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 7 of 19

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD

Z-1637-2021

Recall number: Z-1637-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 625 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 19102741, 200127, 2001246, 2101242

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 8 of 19

10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC

Z-1638-2021

Recall number: Z-1638-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 19112827, 2002440

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 9 of 19

10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK

Z-1639-2021

Recall number: Z-1639-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 330 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 2001201, 2003859, 20051288, 20061419

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 10 of 19

8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB

Z-1640-2021

Recall number: Z-1640-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 20061432

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 11 of 19

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK

Z-1641-2021

Recall number: Z-1641-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 160 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 2001185, 2001243, 20051163

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 12 of 19

CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS

Z-1642-2021

Recall number: Z-1642-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 1000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 2001185, 2001243, 20051163

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 13 of 19

11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD

Z-1643-2021

Recall number: Z-1643-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 2002437

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 14 of 19

11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK

Z-1644-2021

Recall number: Z-1644-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 20051162

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 15 of 19

8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB

Z-1645-2021

Recall number: Z-1645-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 30061432

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 16 of 19

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK

Z-1646-2021

Recall number: Z-1646-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 305 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 2002439, 20051290, 20061420, 20081943

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 17 of 19

10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15

Z-1647-2021

Recall number: Z-1647-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 20071561

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 18 of 19

10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC

Z-1648-2021

Recall number: Z-1648-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 20102495

Distribution pattern

US Nationwide distribution in the states MS and KY.

device · product 19 of 19

10 GAUGE DRILL, CODE INTVM-DRL

Z-1649-2021

Recall number: Z-1649-2021
Initiated: March 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: BIOPSYBELL S.R.L.
Quantity: 75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products labeled as sterile were distributed, but may not have been sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

Code information

LOT: 20102486

Distribution pattern

US Nationwide distribution in the states MS and KY.