The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0623-2014·Announced 2014-01-15

Aesculap Recalls Hi-Line XXS Handpieces Due to Possible Failure

Aesculap, Inc. is recalling 14 Hi-Line XXS handpieces due to a possible failure of the device. The handpieces are used to hold burrs that cut and shape bone.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for bone cutting with a possible failure, representing a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Aesculap, Inc. is recalling 14 units of the Hi-Line XXS handpiece (part number GB790R). The recall is being conducted due to a possible failure of the handpiece. These devices are used with HiLAN and microspeed motor systems to hold burrs which cut and shape bone.

The affected lots include lot numbers 4504385018, 4504300008, 4504328565, 4504685847, and 4804685865. The products were distributed worldwide, including in the United States (Texas, New York, Pennsylvania, and Tennessee) and internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.

The recalled product

Product
Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
Manufacturer
Aesculap, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
14

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Hi-Line XXS handpiece
  • Part Number - GB790R
  • Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865

Distribution

Distributed in 4 states:

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