Aesculap Implant Systems LLC: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

Agency Publication Date: February 15, 2018

Affected Products

Product: 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-RI

All lots, Model Number: GP111R GP112R GP113R GP113TC GP114R GP115R GP116R GP117R GP118R GP119TC GP120R GP121R GP122R GP123R GP124R GP124TC GP125R GP126R GP126TC GP127R GP128R GP128TC GP129R GP129TC GP133R GP134R GP135R GP136R GP141R GP142R GP143R GP144R GP145R GP146R GP147R GP148R GP149R GP150R GP151R GP152R GP153R GP154R GP155R GP156R GP157R GP158R GP161R GP162R GP163R GP164R GP165R GP166R GP167R GP168R GP169R GP170R GP173R GP174R GP175R GP176R GP177R GP184R GP185R GP186R GP187R GP193R GP194R GP195R GP196R GP224R GP225R GP226R GP228R GP229R GP230R GP232R GP233R GP234R GP235R GP236R GP238R GP240R GP241R GP242R GP243R GP301R GP301TC GP302R GP302TC GP303R GP304R GP304TC GP305R GP306R GP306TC GP307R GP307TC GP308R GP308TC GP309R GP309TC GP311R GP312R GP313R GP314R GP315R GP316R GP317R GP321R GP322R GP323R GP324R GP325R GP328R GP329R GP330R GP335R GP336R GP337R GP338R GP339R GP350R GP355R GP356R GP357R GP358R GP374R GP375R GP376R GP378R GP379R GP380R GP382R GP384R GP385R GP386R GP388R GP389R GP391R GP392R GP393R GP395TC GP397R US792R US793R US794R US771R US772R US773R US774R US775R US776R US777R US783TC US785TC US787R US788TC US790TC US800R US801R US807R US852TC US853R US861R US825R US831R

Product: ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DR

All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R

Product: 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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79068

Status: Resolved

Manufacturer: Aesculap Implant Systems LLC

Manufactured In: United States

Units Affected: 3 products (10984; 6211; 6211)

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Sources: FDA iRES · Raw API Response

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Affected Products

All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R