Stryker Leibinger Recalls Non-Sterile Medpor Implant Sizer Sets Due to Labeling Error
Stryker Leibinger is recalling specific non-sterile Medpor implant sizer sets because they were incorrectly labeled as sterile. The recall covers 619 units distributed in the US and several international countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding sterility status, which is a significant issue but does not involve a direct structural defect or reported injuries in the source text.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling specific non-sterile sizer sets used as accessories to Medpor implants. The affected products include the 9805 Orbital Volume Sizer Set with Tray, 9951 Design M Malar Sizer Set, 9952 Extended Contoured Malar Sizer Set, and 85000 Petite Nasal Dorsum Sizer Set. The recall involves 619 units in total.
The reason for the recall is an incorrect sterility status on the labels. The products are non-sterile but were labeled as sterile. This labeling error could lead to improper handling or use of the devices.
The affected lots are M1311023, M1305001, M1603004, and M1603003. These products were distributed nationwide in the United States and in Australia, Canada, Chile, Spain, South Africa, and Taiwan. Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected products if found.
The recalled product
- Product
- 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Affected units
- 619
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Non-Sterile) Lot M1305001 9952 Extended Contoured
- Malar Sizer Set (Silicone
- Non-Sterile) Lot M1603004 85000 Petite Nasal Dorsum Sizer Set (Silicone
- Non-Sterile) Lot M1603003
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Leibinger GmbH & Co. KG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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