Food, drugs, devices › Aesculap Implant Systems LLC
Device recall: 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 R
FDA enforcement event 79068 is a device recall by Aesculap Implant Systems LLC of Center Valley, PA, initiated 5 Sep 2017 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 20 Sep 2019. Initiation: voluntary: firm initiated. Aesculap Implant Systems LLC has 35 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aesculap Implant Systems LLC, Center Valley, PA.
Reason for recall
"ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance."
Distribution
"Distributed to 4 hospitals in the following states: NM, OH, TX, WV"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0619-2018 | 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… | 10984 | Class II | Terminated | 21 Feb 2018 |
| Z-0620-2018 | 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… | 6211 | Class II | Terminated | 21 Feb 2018 |
| Z-0621-2018 | 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… | 6211 | Class II | Terminated | 21 Feb 2018 |
Context
Other enforcement events for Aesculap Implant Systems LLC
All 35 events for Aesculap Implant Systems LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to 4 hospitals in the following states: NM, OH, TX, WV"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Sep 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.