Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN Recalled by Aesculap Implant Systems LLC Due to ELAN 4 burr/blade accessories were marketed without 510(k)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap Implant Systems LLC directly.
Affected Products
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC D2.0 ELAN 4 1-RING ROSEN BURR D2.3 ELAN 4 1-RING ROSEN BURR+ D2.3 ELAN 4 1-RING ROSEN BURR D2.7 ELAN 4 1-RING ROSEN BURR+ D2.7 ELAN 4 1-RING ROSEN BURR D3.0 ELAN 4 1-RING ROSEN BURR TC D3.0 ELAN 4 1-RING ROSEN BURR D3.5
Quantity: 10984
Why Was This Recalled?
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Where Was This Sold?
This product was distributed to 4 states: NM, OH, TX, WV
About Aesculap Implant Systems LLC
Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report