Recall record at a glance
| Official record | Z-0621-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Aesculap Implant Systems LLC |
| Report date | Feb 21, 2018 |
| Recall initiation date | Sep 5, 2017 |
| Quantity | 6211 |
| Location | Center Valley, PA, United States |
Official product 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
Why the product was recalled
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Distribution information
Distributed to 4 hospitals in the following states: NM, OH, TX, WV
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.