The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1137-2022·Announced 2022-06-01

Progenamatrix Human Keratin Matrix Recalled for Inadequate Pouch Seal

ProgenaCare is recalling progenamatrix Human Keratin Matrix due to inadequate inner pouch seals that may compromise sterility. The recall affects 547 packages distributed in Alabama, Georgia, Florida, Tennessee, and Texas.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. However, the compromised sterility seal on a sterile medical device creates a risk of microbial contamination. Per the rubric, with no reported harm and theoretical risk only, the score is 3 (High).

Plain-English summary

ProgenaCare is recalling progenamatrix Human Keratin Matrix, a sterile prescription medical device, due to potentially inadequate inner pouch seals. The recall affects 547 packages in five model sizes distributed in Alabama, Georgia, Florida, Tennessee, and Texas.

The manufacturer identified that the inner pouch seal may be inadequate, which could result in loss of sterility. A compromised seal may allow contamination to occur during product storage or transit.

Healthcare providers and facilities should identify and isolate any affected product immediately using the lot numbers and model numbers provided. Do not use affected products. Contact ProgenaCare for instructions on returning or replacing the recalled devices.

Affected models and lot numbers include: Model PM2012 (lots 02SEP21-001 and 29SEP21-001), Model PM3002 (lot 28OCT21-001), Model PM3004 (lots 02DEC21-001, 02SEP21-002, 14OCT21-001, 23NOV21-001), Model PM3006 (lots 02SEP21-003, 03DEC21-001, 14OCT21-002, 23NOV21-002), and Model PM3010 (lots 13JUL21-001 and 15JUL21-002).

The recalled product

Product
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.
Manufacturer
ProgenaCare
Category
Medical Device — Tissue Matrix
Hazard
Affected units
547

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (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
  • lot #14OCT21-001
  • and 23NOV21-001
  • exp. 10/1/2023. (4) Model PM3006
  • lot #02SEP21-003
  • lot #03DEC21-001
  • lot #14OCT21-002
  • and lot #23NOV21-002
  • exp. 10/1/2023. (5) Model PM3010
  • lot #13JUL21-001
  • and lot #15JUL21-002

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

Same hazard · loss of sterility

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