Recall Z-1406-2021— Centinel Spine, Inc.

Name: FDA recall Z-1406-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Class II · Terminated

Class II FDA medical device recall by Centinel Spine, Inc., initiated 2021-03-05, terminated 2021-08-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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..

Recalling firm: Centinel Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-05
Terminated: 2021-08-02
Firm location: West Chester, PA, United States

Product 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.