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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82636

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

Open FDA event record

Event summary

Timeline bucket
April 12, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Geistlich Pharma North America, Inc.

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

3 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 3

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

Z-2145-2019
Recall number
Z-2145-2019
Initiated
April 12, 2019
Classification
Class II
Status
Terminated
Quantity
244,268 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

Code information

Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.

Distribution pattern

US Nationwide distribution.

device · product 2 of 3

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

Z-2146-2019
Recall number
Z-2146-2019
Initiated
April 12, 2019
Classification
Class II
Status
Terminated
Quantity
244,268 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

Code information

Lots: 81600760, 81700194, 81700829, 81800289, 81800863.

Distribution pattern

US Nationwide distribution.

device · product 3 of 3

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

Z-2147-2019
Recall number
Z-2147-2019
Initiated
April 12, 2019
Classification
Class II
Status
Terminated
Quantity
244,268 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

Code information

Lots: 81700464, 81700811, 81800292, 81800866.

Distribution pattern

US Nationwide distribution.