The Recall Desk
SevereFDA (Devices)·Z-2501-2020·Announced 2020-07-15

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

CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cage because reports indicate the device 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 involves a structural defect (fracturing) in a medical device, which aligns with the rubric criterion for 'structural vehicle defect' or significant injury/property-damage reports, warranting a Severe classification.

Plain-English summary

CTL Medical Corporation is recalling 39 units of the CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. The recall is being conducted because reports were received indicating that the device fractured during insertion.

The affected units are identified by lot numbers 14LDDOCB, 15CNDOBC, 15DIDOCC, and 7FGAD. Distribution of these devices was made to Arizona, Florida, Indiana, Kansas, Massachusetts, Michigan, New York, Tennessee, and Texas.

Healthcare providers and facilities that have received these devices should stop using them and contact CTL Medical Corporation for further instructions on the recall.

The recalled product

Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
Affected units
39

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 (4)

  • Lot numbers 14LDDOCB
  • 15CNDOBC
  • 15DIDOCC
  • and 7FGAD.

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 →