CLASS II Device recall · Reported 27 Mar 2019 · FDA Enforcement Report

Hex Driver MIS, 1/4" Square QC, 0 Ratcheting recalled by CTL Medical

CTL Medical is recalling CTL Medical Hex Driver MIS, 1/4" Square QC, 0 Ratcheting. The recall was initiated on 5 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 7EQBB-C

Quantity recalled133 total devices

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-1031-2019
FDA event ID: 82201
Recalling firm: CTL Medical, Addison, TX
Classification: Class II
Status: Terminated
Recall initiated: 5 Jul 2018
FDA classified: 20 Mar 2019
Reported: 27 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

5 Jul 2018	Recall initiated by company
20 Mar 2019	Classified by FDA	+258 days
27 Mar 2019	Published in enforcement report	+7 days

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

Reason for recall

the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050

Where it was distributed

distributor and user level

Questions about this recall

Is Hex Driver MIS, 1/4" Square QC, 0 Ratcheting recalled?

Yes. CTL Medical recalled Hex Driver MIS, 1/4" Square QC, 0 Ratcheting on 5 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-1031-2019.

Why was it recalled?

Which lots are affected?

Lot 7EQBB-C

Where was it sold?

distributor and user level

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 L26, H8mm 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, 1/4" Square QC, 0 Ratcheting recalled by CTL Medical	CTL Medical	Lead & Heavy Metals	TX

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