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Terminated

Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.

FDA Recall Z-0446-2012 · Posted 2012-01-11

Recalling FirmOSTEOPORE INTERNATIONAL PTE LTD
Recall StatusTerminated
Product CodeGXP
Date Initiated2011-04-27
Date Terminated2012-06-06
Product Quantity330

Reason for Recall

Product sterility may be compromised.

Firm Action

Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution - one distributor in TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051093OSTEOPORE PCL SCAFFOLDOsteopore, Inc. · 2006-03-17

Official Source

View FDA Recall →

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

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