Centinel Spine recalls Prodisc C intervertebral disc implants missing the UP etching on the superior plate, which can lead to improper placement during surgery. Affected units sold from 2020-06-01.
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.
Centinel Spine is recalling Prodisc C spinal implants that may lack the "UP" etching on the superior plate. This could cause improper surgical placement if the surgeon doesn't follow the correct orientation. The recall affects patients who received the device for cervical disc reconstruction.
The "UP" etching helps surgeons orient the device correctly during implantation. Without this marking, the device might be placed incorrectly, potentially causing improper spinal alignment or complications during surgery.
Patients who received the Prodisc C implant for cervical disc reconstruction are most at risk. The recall applies to units with specific part numbers and lot numbers sold starting June 2020.
Check for the "UP" etching on the superior plate of the Prodisc C device. Affected units have part number 09.820.055S and lot number 2020-0600, sold starting June 2020.
Look for the "UP" etching on the superior plate of the Prodisc C device. If missing, the unit is affected.
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate, which is critical for proper surgical placement.
Check for the "UP" etching on the superior plate. If missing, contact Centinel Spine to confirm if your unit is affected.
The recall does not include a remedy; affected units must be checked for the marking and verified with the manufacturer.
We’ve drafted a message you can send Centinel Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-1406-2021 — Centinel Spine Centinel Spine Hello, I own a Centinel Spine that is covered by recall Z-1406-2021 from Centinel Spine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
