The Recall Desk
HighFDA (Devices)·Z-1406-2022·Announced 2022-07-27

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.

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 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
Category
Medical Device — Spinal Surgery Instrument
Hazard
  • implant-deformation
  • surgical-instrument-defect

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:

  • CO

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