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HI-LINE XXS

Aesculap AG · Model GE813SU · UDI-DI 04046963935184

GEY Prescription
10
510(k) clearances
18,194
Adverse events
27
Recalls
147
Facilities

Description

HI-LINE XXS DIAM.NEURO CUTTER II D3.0MM

Recalls

DateFirmReason
2023-02-15Pro-Dex IncBattery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch
2018-09-25Pro-Dex IncVisual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
2017-03-28Aesculap Implant Systems LLCDiamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m
2017-03-28Aesculap Implant Systems LLCDiamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m
2017-03-28Aesculap Implant Systems LLCDiamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.