ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4 1-RING NEURO CUTTER D2.5 ELAN 4 1-RING NEURO CUTTER D3.0 ELAN 4 1-RING NEURO CUTTER TC D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING NEURO CUTTER SOFT D2,0 ELAN 4 2-RING NEURO CUTTER SOFT D2,5 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER TC D3,0 ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 ELAN 4 2-RING DIAMOND DISC ELAN 4 2-RING SIDE CUTTER TC D3,0 SAW BLADE S sagittal 11/13/0,3 SAW BLADE S sagittal 15/5/0,3 SAW BLADE S sagittal 20/5/0,3 SAW BLADE S sagittal 20/10/0,3 SAW BLADE S sagittal 20/15/0,3 SAW BLADE S sagittal 25/5/0,3 SAW BLADE S sagittal 25/12/0,3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 ELAN 4 1-RING NEURO CUTTER D1.5+ ELAN 4 1-RING NEURO CUTTER D2.0+ ELAN 4 1-RING NEURO CUTTER D2.5+ ELAN 4 1-RING NEURO CUTTER D3.0+ ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 ELAN 4 1-RING NEURO PRECISE D1.5 ELAN 4 1-RING NEURO PRECISE D2.0 ELAN 4 1-RING NEURO PRECISE D2.5 ELAN 4 1-RING NEURO PRECISE D3.0 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5

Class I - Dangerous

🏥 Medical Devices Recalled: September 5, 2017 Aesculap Implant Systems Other Medical Devices

What Should You Do?

Check if you have this product:
All lots, Model Number: GP190R GP201R GP202R GP203R GP204R GP205R GP208R GP209R GP210R GP210TC GP211R GP212R GP213R GP214R GP215R GP216R GP217R GP218R GP219R GP220R GP341R GP342R GP343R GP351R GP352R GP353R GP361R GP362R GP363R GP364R GP367R GP367TC GP370R GP371R GP398SU GP399TC-SU GP491R GP492R GP493R GP494R GP495R GP496R GP497R GP542R GP543R GP544R GP545R US779R US780R US781R US782R US784TC US792R US793R US794R US795R US798TC US799TC US800R
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Aesculap Implant Systems LLC
Reason for Recall:: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4 1-RING NEURO CUTTER D2.5 ELAN 4 1-RING NEURO CUTTER D3.0 ELAN 4 1-RING NEURO CUTTER TC D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING NEURO CUTTER SOFT D2,0 ELAN 4 2-RING NEURO CUTTER SOFT D2,5 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER TC D3,0 ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 ELAN 4 2-RING DIAMOND DISC ELAN 4 2-RING SIDE CUTTER TC D3,0 SAW BLADE S sagittal 11/13/0,3 SAW BLADE S sagittal 15/5/0,3 SAW BLADE S sagittal 20/5/0,3 SAW BLADE S sagittal 20/10/0,3 SAW BLADE S sagittal 20/15/0,3 SAW BLADE S sagittal 25/5/0,3 SAW BLADE S sagittal 25/12/0,3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 ELAN 4 1-RING NEURO CUTTER D1.5+ ELAN 4 1-RING NEURO CUTTER D2.0+ ELAN 4 1-RING NEURO CUTTER D2.5+ ELAN 4 1-RING NEURO CUTTER D3.0+ ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 ELAN 4 1-RING NEURO PRECISE D1.5 ELAN 4 1-RING NEURO PRECISE D2.0 ELAN 4 1-RING NEURO PRECISE D2.5 ELAN 4 1-RING NEURO PRECISE D3.0 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5

Product Codes/Lot Numbers:

All lots, Model Number: GP190R GP201R GP202R GP203R GP204R GP205R GP208R GP209R GP210R GP210TC GP211R GP212R GP213R GP214R GP215R GP216R GP217R GP218R GP219R GP220R GP341R GP342R GP343R GP351R GP352R GP353R GP361R GP362R GP363R GP364R GP367R GP367TC GP370R GP371R GP398SU GP399TC-SU GP491R GP492R GP493R GP494R GP495R GP496R GP497R GP542R GP543R GP544R GP545R US779R US780R US781R US782R US784TC US792R US793R US794R US795R US798TC US799TC US800R

Distribution:

Distributed in: NM, OH, TX, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0621-2018

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