CTL Medical Hex Driver Recall Due to Anti-Toggle Ring Separation Risk
CTL Medical is recalling 133 Hex Driver MIS units because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.
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 in a surgical instrument that can lead to construct failure during a procedure, meeting the criteria for a Severe rating.
Plain-English summary
CTL Medical Corporation is recalling 133 units of the CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting (Ref 019.7050, Lot 7EQBB-C). The recall was initiated because the anti-toggle ring of the hex driver may separate from the driver shaft.
If the anti-toggle ring separates during surgery, it can be pressed into the pedicle screw head. This interference can cause the screw to separate from the housing upon tightening or prevent the final tightening of the pedicle screw construct. Such failure can lead to the release of the rod from the construct.
The devices were distributed at the distributor and user level. Healthcare providers and facilities should stop using the affected devices and contact CTL Medical Corporation for further instructions.
The recalled product
- Product
- CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
- Manufacturer
- CTL Medical Corporation
- Affected units
- 133
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 (1)
- Lot 7EQBB-C
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · CTL Medical Corporation
See all →- SevereCTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracture Reports
FDA (Devices) · 2020-07-15
- SevereCTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cages Due to Fracturing
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- SevereCTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing
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- SevereCTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing
FDA (Devices) · 2020-07-15
- SevereCTL Medical Hex Driver Recalled Due to Anti-Toggle Ring Separation Risk
FDA (Devices) · 2019-03-27
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