The Recall Desk
SevereFDA (Devices)·Z-0126-2017·Announced 2016-10-26

X Spine Systems Recalls Calix T PEEK Lumbar System TLIF Rasps

X Spine Systems is recalling 195 units of Calix T PEEK Lumbar System TLIF Rasps because the tools may detach and become lodged in the surgical site.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect where surgical instruments may detach and become lodged in the patient's body, posing a significant risk of injury.

Plain-English summary

X Spine Systems Inc is recalling 195 units of the Calix T PEEK Lumbar System, TLIF Rasp. The affected products include specific sizes (28mm x 10mm x 6mm and 28mm x 10mm x 10mm) and associated part and lot numbers. The recall is classified as Class II by the U.S. Food and Drug Administration.

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 Puerto Rico, as well as to Australia, England, Germany, Italy, Mexico, Portugal, and the United Kingdom. Healthcare providers and patients who have used these specific rasps should contact X Spine Systems Inc for further instructions.

The recalled product

Product
Calix T PEEK Lumbar System, TLIF Rasp
Manufacturer
X Spine Systems Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
195

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
  • 28mm x 10mm x 6mm
  • Part #:
  • X034-0360
  • Lot #:
  • 23515
  • 23516
  • 24295
  • 24836
  • 24836s1
  • 24836S2
  • 657001
  • 760913 & Size
  • 28mm x 10mm x 10mm
  • X034-0364
  • 23517
  • 23518
  • 24296
  • 24837
  • 657002

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 →

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