Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants
Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device recall involving potential implant deformation during spinal surgery. The FDA classified it as Class II. However, no illnesses, injuries, or hospitalizations have been reported in the source text, keeping the severity at High rather than Severe.
Plain-English summary
Aesculap Implant Systems LLC has issued a recall for the LEFT CORONAL BENDER, model TEK1939, a surgical instrument used during spinal procedures. According to the recall, the instrument may deform the implant when used with spinal system devices.
The recalled product consists of 2 units from lot 2930901A, distributed in Colorado. This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 2
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: 2930901A
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Aesculap Implant Systems LLC 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.
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