FDA Medical Device Recalls (openFDA)
OSTEOPORE INTERNATIONAL PTE LTD: Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
- Recall number
- Z-0446-2012
- Recalling firm
- OSTEOPORE INTERNATIONAL PTE LTD
- Product
- Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
- Status
- Terminated
- Initiated
- 2011-04-27
- Posted
- 2012-01-11
- Terminated
- 2012-06-06
- Reason
- Product sterility may be compromised.
- Root cause
- Nonconforming Material/Component
- Action
- Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.
- Quantity
- 330
- Distribution
- Nationwide distribution - one distributor in TX.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K051093"]
- PMA numbers
- not on file
- Product code
- GXP
- Firm FEI
- 3007303685
- Firm city
- SINGAPORE
- Firm state
- not on file
- Firm country
- SINGAPORE
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28