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
Check against the official notice below — it lists the full affected range.
Centinel Spine, Inc. is recalling 49 Prodisc C intervertebral disc devices used in neck surgery due to a missing "UP" etching on the superior plate. The "UP" marking is designed to help surgeons orient the device correctly during implantation into the disc space between vertebrae C3-C7. The company discovered this defect through five customer complaints. The affected devices were distributed nationwide to hospitals and surgical centers in California, Maryland, Washington DC, Tennessee, Georgia, North Carolina, Pennsylvania, Kentucky, New York, Arizona, Colorado, Ohio, Florida, and Michigan, and are identified by lot number 2020-0600.
While the devices are missing this orientation marking, surgeons had alternative orientation guides available in the surgical technique documentation, packaging, and instrumentation accompanying the product. The recall record does not specify a remedy for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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 Lot/code info: UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.