Addison, TX, United States
CTL Medical Corporation recalls
2 recalls recorded since 2018, most recently on 21 August 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 21 August 2019
- Reason
- Reports received of the device fracturing during insertion.
- Distribution
- Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2502-2020, Z-2504-2020, Z-2503-2020, Z-2501-2020
- CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
- CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
- CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
- CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
Terminated Class II Medical devices
- Recall started
- 5 July 2018
- Terminated
- 28 April 2021
- Reason
- 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.
- Distribution
- distributor and user level
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1030-2019, Z-1031-2019
- CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
- CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.