Onkos My3D Personalized Pelvic Implant Recalled for Distribution Error
Onkos Surgical is recalling My3D Personalized Pelvic Implants that were inadvertently mixed up and distributed to incorrect customers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Class II because the personalized implants were distributed to incorrect customers, creating a risk of using a device not intended for the specific patient's anatomy. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Onkos Surgical, Inc. is recalling its My3D Personalized Pelvic Implant, Porous, Left (REF PV-ACREC-04M). The recall is due to a distribution error where personalized pelvic implants were inadvertently mixed up and sent to the wrong customers.
The affected product is identified by UDI B278PVACREC04M0 and Lot # C26-0346. The source indicates the product was distributed in North Carolina and California. The source does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients who have received this specific implant should contact Onkos Surgical, Inc. for further instructions regarding the recall and potential replacement or removal of the device.
The recalled product
- Product
- Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 1
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 (2)
- UDI: B278PVACREC04M0-Lot# C26-0346
- Case# C26-0346
Distribution
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