The Recall Desk
SevereFDA (Devices)·Z-2504-2020·Announced 2020-07-15

CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cages Due to Fracturing

CTL Medical Corporation is recalling 46 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.

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. The hazard involves a structural failure (fracturing) of a spinal implant during insertion, which poses a significant risk of injury to the patient, meeting the criteria for a Severe rating.

Plain-English summary

CTL Medical Corporation is recalling 46 units of CEZANNE II TLIF Bullet-Tip Cages, 8Deg, W11 x L30, H8mm, Part #018.1908. The recall was initiated after reports were received that the devices fractured during insertion.

The affected units are identified by lot numbers 14LEDOEB, 15CNDOHC, and 15DJDOHC. Distribution of these devices was made to Arizona, Florida, Indiana, Kansas, Massachusetts, Michigan, New York, Tennessee, and Texas.

Healthcare providers and facilities should stop using the affected devices and contact CTL Medical Corporation for further instructions on the recall.

The recalled product

Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
Manufacturer
CTL Medical Corporation
Category
Medical Device — Spinal Implant
Hazard
Affected units
46

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 (3)

  • Lot numbers 14LEDOEB
  • 15CNDOHC
  • and 15DJDOHC.

Distribution

Distributed in 9 states:

Part of a larger recall action

This product is one of 4 recalled by CTL Medical Corporation 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 · CTL Medical Corporation

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Same hazard · structural failure

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