Z-0446-2012

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

Name: Z-0446-2012 Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh
Creator: Osteopore International Pte Ltd
Published: 2011-04-27
License: https://open.fda.gov/license/

Osteopore International Pte Ltd / initiated 2011-04-27 / Terminated / root cause: manufacturing process

FDA source

OSTEOPORE INTERNATIONAL PTE LTD began a recall of Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh on 2011-04-27. The reason FDA records is "Product sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0446-2012
Status: Terminated
Initiated: 2011-04-27
Posted: 2012-01-11
Terminated: 2012-06-06
Recalling firm: Osteopore International Pte Ltd
Product: Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
Product code: GXP Methyl Methacrylate For Cranioplasty
Reason for recall: Product sterility may be compromised.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.
Quantity in commerce: 330
Distribution: Nationwide distribution - one distributor in TX.
Product codes and lots: Serial number LP-07-000695-714, lot number P0009032007-NW-05, expiry date Jul-12; Serial number TT-07-002201-2500, lot number P0009032007-NW-05, expiry date Sep-12; and Serial number PL-09-000006 to 15, lot number P0010112007-NW-05, expiry date Dec-12.

Product code GXP

K051093Class IIOsteopore Pcl ScaffoldOsteopore, Inc. / cleared 2006-03-17

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)