FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1406-2021
- Recalling firm
- Centinel Spine, Inc.
- 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
- Status
- Terminated
- Initiated
- 2021-03-05
- Posted
- not on file
- Terminated
- 2021-08-02
- 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.
- Lot, serial or model codes
- UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600
- 510(k) numbers
- not on file
- PMA numbers
- ["P070001"]
- Product code
- MJO
- Firm FEI
- 3007494564
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28