Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ C
FDA device recall Z-2182-2014 · posted 2014-08-11 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery.
- Action taken
- The firm, Integra, sent an "URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE" dated June 27, to its customers. The letter informs the customers that Integra Lifesciences is recalling the Integra NewPort MIS System because there is a possibility that the components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in the surgery. The letter also informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached response form and return it by email or fax as indicated on the form. Customers with questions regarding the recall letter instructions are instructed to contact the Marketing Manager at (760) 207-7050.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 4 units
- Distribution
- US Distribution in TX only.
- Date initiated
- 2014-06-27
- Date posted
- 2014-08-11
- Date terminated
- 2014-09-16
- Location
- Plainsboro, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWPORT SPINAL SYSTEM (K083089) | Seaspine, Inc. | 2009-01-13 |