IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242
FDA device recall Z-2452-2023 · posted 2023-08-24 · Open, Classified
Recall details
- Recalling firm
- Medicrea International
- Reason for recall
- There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- Action taken
- Beginning 12 July 2023, In the U.S. Medtronic disseminated an URGENT: MEDICAL PRODUCT RECALL to its consignees via UPS 2-Day delivery. The notice explained the problem, risk, and requested the following: Medtronic requests that you immediately take the following actions: Identify and quarantine any unused impacted product(s). Return all unused and non-expired product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 248 units
- Distribution
- US nationwide
- Date initiated
- 2023-07-12
- Date posted
- 2023-08-24
- Location
- Vancia Vancia Rillieux La Pape, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPIX 3D Print Cages (K163595) | Medicrea International SA | 2017-11-13 |