Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C… recallZ-0446-2012 · Osteopore International Pte Ltd · initiated Apr 27, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Osteopore International Pte Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product sterility may be compromised.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.
Recall details
- Recall number
- Z-0446-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 27, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Osteopore International Pte Ltd
- Quantity
- 330
- Product code
- GXP
- FDA submissions
- K051093
- Distribution
- Nationwide distribution - one distributor in TX.
Product description
Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
4 devices cleared under K051093 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Osteostrip PC17(100,2,4)Osteopore International Pte. Ltd. · Methyl Methacrylate For Cranioplasty1 report
- Osteomesh PC12(39,10,1)Osteopore International Pte. Ltd. · Methyl Methacrylate For Cranioplasty1 report
- Osteoplug NEBP-1305-POsteopore International Pte. Ltd. · Methyl Methacrylate For Cranioplasty1 report
- Osteoplug PC22(14,14,4)Osteopore International Pte. Ltd. · Methyl Methacrylate For Cranioplasty1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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