Centinel Spine, Inc. Recall 87530
Description: Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
Centinel Spine, Inc. Recall 87530 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1406-2021 |
| Event ID | 87530 |
| Event Description | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI. |
| Quantity | 49 devices |
| Recall Reason | Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product. |
| Device Classification | 20210421 |
| Device Code Info | UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600 |
| Center Classification Date | 20210409 |
| Recall Initiation Date | 20210305 |
| Recalling Firm | Centinel Spine, Inc. |
| Initial Notification | Letter |
| Similar To |