Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage Risk
Aesculap Implant Systems LLC is recalling ELAN 4 2-Ring Diamond Burrs because diamond 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 soft 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 specific ELAN 4 2-Ring Diamond Burrs (models GP321R, GP322R, GP323R, GP324R, and GP325R) due to a risk of diamond particulates breaking off the instrument. The recall covers a total of 608 units that were distributed nationwide in the United States, specifically in California, Illinois, New York, Pennsylvania, Tennessee, and Texas.
The hazard involves diamond particles detaching from the burr and falling into the surgical site. If these particles are not detected and removed, they may cause a foreign body reaction or mechanically induced soft tissue damage. The ELAN 4 motor system and Hi-Line XS handpiece are intended for high-speed cutting, sawing, drilling, and manipulation of soft tissue and bone in Spine, ENT, Neuro, and Maxillofacial Surgery.
This is an FDA Class II recall. Healthcare providers and facilities that have received these specific burr models should stop using them and contact Aesculap Implant Systems LLC for instructions on return or replacement.
The recalled product
- Product
- GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The ELAN
- Manufacturer
- Aesculap Implant Systems LLC
- 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 (5)
- Model numbers: GP321R
- GP322R
- GP323R
- GP324R
- GP325R
Distribution
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.
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