CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

Elan 4 Burr: Elan 4 1-Ring Rosen Burr+ D0.6 Elan 4 1-Ring recalled

Aesculap Implant Systems is recalling Elan 4 Burr: Elan 4 1-Ring Rosen Burr+ D0.6 Elan 4 1-Ring Rosen Burr+ D0.8 Elan 4 1-Ring, distributed in New Mexico, Ohio, Texas, West Virginia. The recall was initiated on 5 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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

Quantity recalled10984

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0619-2018
FDA event ID: 79068
Recalling firm: Aesculap Implant Systems, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 5 Sep 2017
FDA classified: 15 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Sep 2017	Recall initiated by company
15 Feb 2018	Classified by FDA	+163 days
21 Feb 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

Product as listed by the FDA

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

Where it was distributed

Distributed to 4 hospitals in the following states: NM, OH, TX, WV

New Mexico Ohio Texas West Virginia

Questions about this recall

Why was it recalled?

ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

Which lots are affected?

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

Where was it sold?

Distributed to 4 hospitals in the following states: NM, OH, TX, WV

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 79068

This product is part of a recall event; the main page for the event is Elan 4 Blade: Elan 4 1-Ring Pin Cutter D1.0 Elan 4 1-Ring recalled.

Reported	Class	Recall	Company	Reason	Where
21 Feb 2018	CLASS II	Elan 4 Blade: Elan 4 1-Ring Pin Cutter D1.0 Elan 4 1-Ring recalled	Aesculap Implant Systems	Other	4 states
21 Feb 2018	CLASS II	Elan 4 Drill: Elan 4 1-Ring Twist Drill D1.5 Elan 4 1-Ring recalled	Aesculap Implant Systems	Other	4 states

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