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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87848

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

Open FDA event record

Event summary

Timeline bucket
March 29, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nobel Biocare Procera LLC

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

5 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 5

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339

Z-1677-2021
Recall number
Z-1677-2021
Initiated
March 29, 2021
Classification
Class II
Status
Terminated
Recalling firm
Nobel Biocare Procera LLC
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not manufactured to specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not manufactured to specification

Code information

Serial Numbers: 173943674, 173943711

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.

device · product 2 of 5

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

Z-1678-2021
Recall number
Z-1678-2021
Initiated
March 29, 2021
Classification
Class II
Status
Terminated
Recalling firm
Nobel Biocare Procera LLC
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not manufactured to specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not manufactured to specification

Code information

Serial Numbers: 173939852, 173940027, 173940107, 173940346, 173940844, 173940852, 173942662

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.

device · product 3 of 5

NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363

Z-1679-2021
Recall number
Z-1679-2021
Initiated
March 29, 2021
Classification
Class II
Status
Terminated
Recalling firm
Nobel Biocare Procera LLC
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not manufactured to specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not manufactured to specification

Code information

Serial Numbers: 173940845

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.

device · product 4 of 5

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364

Z-1680-2021
Recall number
Z-1680-2021
Initiated
March 29, 2021
Classification
Class II
Status
Terminated
Recalling firm
Nobel Biocare Procera LLC
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not manufactured to specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not manufactured to specification

Code information

Serial Numbers: 173943753

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.

device · product 5 of 5

NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387

Z-1681-2021
Recall number
Z-1681-2021
Initiated
March 29, 2021
Classification
Class II
Status
Terminated
Recalling firm
Nobel Biocare Procera LLC
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not manufactured to specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not manufactured to specification

Code information

Serial Numbers: 173942675

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.