The Recall Desk
HighFDA (Devices)·Z-2087-2017·Announced 2017-05-24

Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage

Aesculap Implant Systems LLC is recalling 608 ELAN 4 diamond burrs because particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.

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: The recall is classified as FDA Class II, and the source describes a risk of harm (foreign body reaction and tissue damage) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aesculap Implant Systems LLC is recalling 608 units of ELAN 4 1-Ring and 2-Ring Diamond Burrs (Coarse and X-Coarse) due to a risk of diamond particulates breaking off the instrument. The affected model numbers include GP161R through GP170R, GP173R through GP177R, and GP328R through GP330R. These surgical instruments are intended for high-speed cutting, sawing, drilling, and manipulation of soft tissue and bone in Spine, ENT, Neuro, and Maxillofacial Surgery.

The recall is issued because diamond particulates may break off the burr and fall into the surgical site. If these particles are not detected and removed, they may cause a foreign body reaction. Additionally, the particulates could lead to mechanically induced soft tissue damage.

The products were distributed nationwide in the United States, specifically in California, Illinois, New York, Pennsylvania, Tennessee, and Texas. Healthcare providers and facilities that have received these specific model numbers should stop using them and contact Aesculap Implant Systems LLC for instructions on return or replacement.

The recalled product

Product
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Surgical Instruments
Hazard
Affected units
608

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 (18)

  • Model numbers COARSE: GP161R
  • GP162R
  • GP163R
  • GP164R
  • GP165R
  • GP166R
  • GP167R
  • GP168R
  • GP169R
  • GP170R
  • Model numbers X-Course: GP173R
  • GP174R
  • GP175R
  • GP176R
  • GP177R
  • GP328R
  • GP329R
  • GP330R

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 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.

See all 3 products in this recall →

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