CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing
CTL Medical Corporation is recalling 45 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 (fracturing) in a medical device, which meets the rubric criteria for a Severe rating.
Plain-English summary
CTL Medical Corporation is recalling 45 units of the CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. The recall was initiated after reports were received that the device fractured during insertion.
The affected units are identified by lot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD. Distribution of these devices was made to Arizona, Florida, Indiana, Kansas, Massachusetts, Michigan, New York, Tennessee, and Texas.
This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Healthcare providers and patients should contact CTL Medical Corporation for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
- Manufacturer
- CTL Medical Corporation
- Hazard
- Affected units
- 45
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 14LEDOAB
- 15CNDOCC
- 15DIDOBC
- and 7FGBD.
Distribution
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
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