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Terminated

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

FDA Recall Z-0476-06 · Posted 2006-02-04

Recalling FirmQLT USA, Inc.
Recall StatusTerminated
Product CodeLYC
Date Initiated2006-01-26
Date Terminated2006-04-27
Product Quantity136 / 3 pack units

Reason for Recall

Injectable needles were included in procedure kits instead of sterile blunt cannulas.

Firm Action

Consignee was notified by letter on 1/26/2006.

Root Cause

Other

Distribution Pattern

PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982865ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KITAtrix Laboratories, Inc. · 1998-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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