Device recall: CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Class II FDA enforcement event 82201. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
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
CTL Medical Corporation started this device recall on 5 Jul 2018. The firm address in the FDA record is in Addison, TX. FDA put the recall in Class II. FDA event 82201 has 2 product records. The first FDA enforcement report date is 27 Mar 2019. The record gives the status Terminated, with the termination date 28 Apr 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
distributor and user level
Recalling firm
CTL Medical Corporation, Addison, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1030-2019 | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 | 133 total devices | Class II | Terminated | 27 Mar 2019 |
| Z-1031-2019 | CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 | 133 total devices | Class II | Terminated | 27 Mar 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 2Median of the firm: 4
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Aug 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-1030-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 82201. https://recallregister.com/fda/ii/82201/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
distributor and user level
- What quantity of product is in FDA event 82201?
- The event has 2 product records. The first record gives this quantity:
133 total devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.