CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report

Cezanne II Tlif Bullet-Tip Cage, 8Deg, W11 x L26, H8mm recalled

CTL Medical is recalling Cezanne II Tlif Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308, distributed in 9 states. The recall was initiated on 21 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD.

Quantity recalled45 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2503-2020
FDA event ID: 85218
Recalling firm: CTL Medical, Addison, TX
Classification: Class II
Status: Completed
Recall initiated: 21 Aug 2019
FDA classified: 4 Jul 2020
Reported: 15 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Aug 2019	Recall initiated by company
4 Jul 2020	Classified by FDA	+318 days
15 Jul 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports received of the device fracturing during insertion.

Product as listed by the FDA

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

Where it was distributed

Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

Arizona Florida Indiana Kansas Massachusetts Michigan New York Tennessee Texas

Questions about this recall

Is Cezanne II Tlif Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308 recalled?

Yes. CTL Medical recalled Cezanne II Tlif Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308 on 21 Aug 2019. The recall is Class II and its status is Completed. Recall number Z-2503-2020.

Why was it recalled?

Reports received of the device fracturing during insertion.

Which lots are affected?

Lot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD.

Where was it sold?

Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CTL Medical

All 6

Reported	Class	Recall	Company	Reason	Where
15 Jul 2020Device	CLASS II	Cezanne II Tlif Bullet-Tip Cage, 8Deg, W11 x L26, H7mm recalled	CTL Medical	Other	9 states
15 Jul 2020Device	CLASS II	Cezanne II Tlif Bullet-Tip Cage, 8Deg, W11 x L30, H8mm recalled	CTL Medical	Other	9 states
15 Jul 2020Device	CLASS II	Cezanne II Tlif Bullet-Tip Cage, 8Deg, W11 x L30, H7mm recalled	CTL Medical	Other	9 states
27 Mar 2019Device	CLASS II	Hex Driver MIS, 1/4" Square QC, 0 Ratcheting recalled by CTL Medical	CTL Medical	Lead & Heavy Metals	TX
27 Mar 2019Device	CLASS II	Hex Driver, 1/4" Square QC, 0 Ratcheting recalled by CTL Medical	CTL Medical	Lead & Heavy Metals	TX

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