Recall Z-1406-2021 ยท MJO Prosthesis, Intervertebral Disc
Centinel Spine, Inc.
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
| Date | Mar 5, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | In March 2021, Centinel issued an Urgent Medical Device Recall notice to customers and distributers via letter and email notifying them the "UP" etching on the superior plate is missing. The "UP" is used to signify that the implant should be inserted into the intradiscal space with "UP" towards the head or in the cephalic position. In those devices with "UP" missing, there is a risk that the device could be placed upside-down within the intradiscal space. |
| Quantity | 49 devices |
| Distribution | US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.