Reported Apr 21, 2021 · Terminated
Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction…
Centinel Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Centinel Spine, Inc. · 900 Airport Rd Ste 3b · West Chester, PA · 19380-3416
Is this the product you have?
- Prodisc C - prosthesis
- intervertebral disc - Product Usageindicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD)
- Part number09.820.055S
- Lot codes and dates
- UDI (01)00843193112842(17)241231(10)2020-0600
- Lot number2020-0600
- Amount recalled
- 49 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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