Z-0476-06

Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile

Name: Z-0476-06 Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
Creator: QLT USA, Inc.
Published: 2006-01-26
License: https://open.fda.gov/license/

QLT USA, Inc. / initiated 2006-01-26 / Terminated / root cause: sterility

FDA source

QLT USA, Inc. began a recall of Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile on 2006-01-26. The reason FDA records is "Injectable needles were included in procedure kits instead of sterile blunt cannulas". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0476-06
Status: Terminated
Initiated: 2006-01-26
Posted: 2006-02-04
Terminated: 2006-04-27
Recalling firm: QLT USA, Inc.
Product: Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
Product code: LYC Bone Grafting Material, Synthetic
Reason for recall: Injectable needles were included in procedure kits instead of sterile blunt cannulas.
Root cause tag: sterility
FDA root cause: Other
Action: Consignee was notified by letter on 1/26/2006.
Quantity in commerce: 136 / 3 pack units
Distribution: PA
Product codes and lots: Lot 2072A, Exp 5/2007

Product code LYC

K982865Class IIAtrisorb Bioabsorbable Guided Tissue Regeneration (Gtr) Barrier KitAtrix Laboratories, Inc. / cleared 1998-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)