Reported Feb 21, 2018 · Terminated
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…
Aesculap Implant Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- ELAN 4 BurrELAN 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
- Lot codes and dates
- All lots
- Model Number
166 of 166 codes
GP111RGP112RGP113RGP113TCGP114RGP115RGP116RGP117RGP118RGP119TCGP120RGP121RGP122RGP123RGP124RGP124TCGP125RGP126RGP126TCGP127RGP128RGP128TCGP129RGP129TCGP133RGP134RGP135RGP136RGP141RGP142RGP143RGP144RGP145RGP146RGP147RGP148RGP149RGP150RGP151RGP152RGP153RGP154RGP155RGP156RGP157RGP158RGP161RGP162RGP163RGP164RGP165RGP166RGP167RGP168RGP169RGP170RGP173RGP174RGP175RGP176R
- Amount recalled
- 10984
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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