ModerateClass IITerminated

FDA Devices recall · Reported February 21, 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 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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0621-2018.

Q: Where was the recalled product distributed?

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

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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

Recall #: Z-0621-2018
Affected scope: 6211
Initiated: September 5, 2017

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Aesculap Implant Systems LLC recalled ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN … - a moderate-severity action.

ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN … was recalled by Aesculap Implant Systems LLC in February 21, 2018. Reason: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.. Check the official notice for the remedy. Verify recall #Z-0621-2018 with the FDA Devices before acting.

The recall

Aesculap Implant Systems LLC issued this moderate-severity FDA Devices recall-ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance..

Moderate
severity level: 6K units
affected scope: Class II
classification: February 21, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0621-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

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

Reason for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0621-2018
Date reported	February 21, 2018
Date initiated	September 5, 2017
Recalling firm	Aesculap Implant Systems LLC
Firm location	Center Valley, PA
Affected scope	6211
Distribution	Distributed to 4 hospitals in the following states: NM, OH, TX, WV

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

6211 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0621-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0621-2018.

Where was the recalled product distributed? ▼

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

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Outdoor Gas Fire Pits Recalled Due to Bur… 2018-02-21 Cost Plus World Market Recalls Bleeding D… 2018-02-21 Q.Care, Oral Cleansing & Suctioning Syste… 2018-02-21 Q Care, Oral Cleansing & Suctioning Syste… 2018-02-21

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Ingenuity TF PET/CT (model 882442) runnin… 2018-02-21 Vado Steerable Sheath 8.8F, REF SS8FMU67,… 2018-02-21 Vado Bi-Directional Steerable Sheath 8.8F… 2018-02-21 BARD(R) CRITICORE(R) MONITOR, Model: 0000… 2018-02-21

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported February 21, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026