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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82638

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Collagen Matrix, 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

1 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 1

Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.

Z-1389-2019
Recall number
Z-1389-2019
Initiated
March 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Collagen Matrix, Inc.
Quantity
45 units -US;170 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

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

Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

Code information

Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255

Distribution pattern

Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.