Surgical Coronal Bender May Deform Spinal Implants During Surgery
Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.
What this means for you
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 an FDA Class II recall for a surgical instrument with potential to cause device malfunction. The hazard is a risk of harm (implant deformation during surgery) with no reported injuries or hospitalizations mentioned in the source. This meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the RIGHT CORONAL BENDER, TEK1940, a surgical instrument manufactured by Aesculap Implant Systems LLC and used during spinal surgery. The recall involves 2 units with lot number 2930902A distributed in Colorado.
Coronal rod benders are used to bend and shape implants during spinal surgical procedures. According to the recall notice, the customized coronal benders may deform the implant when used with spinal system devices, potentially compromising the integrity of the implant.
The recall affects healthcare facilities and surgical teams in Colorado that may have received units from this lot. Healthcare providers should verify their inventory and take appropriate action regarding any recalled units.
The recalled product
- Product
- RIGHT CORONAL BENDER, TEK1940. 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: 2930902A
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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