The Recall Desk
HighFDA (Devices)·Z-0124-2017·Announced 2016-10-26

X Spine Systems Recalls Calix P PEEK Lumbar System PLIF Rasps

X Spine Systems Inc is recalling 182 units of Calix P PEEK Lumbar System PLIF Rasps because the tools may detach and become lodged in the surgical site.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (components becoming lodged in the body) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

X Spine Systems Inc is recalling 182 units of the Calix P PEEK Lumbar System, PLIF Rasp. The recall involves specific sizes (22mm x 10mm x 6mm and 22mm x 10mm x 10mm) and associated part and lot numbers.

The recall is being issued because the trials and rasps used to prepare the surgical site for implant placement may become detached from the inserter assembly part. If this occurs, the detached components may become lodged in the intervertebral space.

The affected products were shipped to 19 U.S. states and territories, as well as seven countries including Australia, England, Germany, Italy, Mexico, Portugal, and the United Kingdom. Healthcare providers and patients should contact X Spine Systems Inc for further instructions regarding the recall and potential replacement or repair of the devices.

The recalled product

Product
Calix P PEEK Lumbar System, PLIF Rasp
Manufacturer
X Spine Systems Inc
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
182

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Size
  • 22mm x 10mm x 6mm
  • Part #:
  • X034-0990
  • Lot #:
  • 015641-2-1
  • 015641-2-1R
  • 015857-24-1
  • 020316
  • 020329
  • 020746
  • 19894
  • UP1009
  • UPI002
  • UPI005
  • UPI008 & Size
  • 22mm x 10mm x 10mm
  • X034-0994
  • 015641-3-1
  • 015641-3-1R

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 4 recalled by X Spine Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · X Spine Systems Inc

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Same hazard · device detachment

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