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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90022

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

Open FDA event record

Event summary

Timeline bucket
April 18, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ProgenaCare

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

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

Z-1137-2022
Recall number
Z-1137-2022
Initiated
April 18, 2022
Classification
Class II
Status
Terminated
Recalling firm
ProgenaCare
Quantity
547 packages

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
pouch seal may be inadequate
Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inner pouch seal may be inadequate resulting in lack of sterility.

Code information

(1) Model PM2012, lot #02SEP21-001, exp. 4/9/2024; lot #29SEP21-001, exp. 4/9/2024. (2) Model PM3002, lot #28OCT21-001, exp. 3/7/2024. (3) Model PM3004, lot #02DEC21-001, exp. 10/1/2023; lot #02SEP21-002, exp. 10/1/2023; lot #14OCT21-001, exp. 10/1/2023; and 23NOV21-001, exp. 10/1/2023. (4) Model PM3006, lot #02SEP21-003, exp. 10/1/2023; lot #03DEC21-001, exp. 10/1/2023; lot #14OCT21-002, exp. 10/1/2023; and lot #23NOV21-002, exp. 10/1/2023. (5) Model PM3010, lot #13JUL21-001, exp. 10/1/2023; and lot #15JUL21-002, exp. 3/6/2024.

Distribution pattern

US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.