Stryker Recalls MEDPOR Titan Max Orbital Floor and Wall Implants
Stryker is recalling MEDPOR Titan Max Orbital Floor and Wall implants due to incorrect barrier location and potential mix-ups with left-sided units.
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, but the source text describes a labeling/configuration error (incorrect barrier location and unit mix-up) without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Craniomaxillofacial Division is recalling MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right implants. The recall involves 1,051 units distributed worldwide, including in the United States and various international markets.
The recall was initiated because the right-sided implants reportedly contained left-sided units (Article #81035) instead of the correct right-sided units (Article #81036). Additionally, the products had an incorrect barrier location. The source text notes that the appropriate articles were actually included in the shipment, but the specific configuration errors described above were present.
These implants are intended for non-weight-bearing applications of craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma. Healthcare providers and patients who have received these specific implants should contact Stryker for further instructions on replacement or corrective action.
The recalled product
- Product
- MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial t
- Manufacturer
- Stryker Craniomaxillofacial Division
- Affected units
- 1,051
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 (3)
- Part Number 81036
- Lot Number A1402020
- A1405060
Distribution
Part of a larger recall action
This product is one of 4 recalled by Stryker Craniomaxillofacial Division 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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