FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: 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.
- Recall number
- Z-0623-2014
- Recalling firm
- Aesculap, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-12-09
- Posted
- 2014-01-03
- Terminated
- 2014-12-02
- Reason
- Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
- Root cause
- Device Design
- Action
- Aesculap sent an Important Correction & Removal Notification letter dated December 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all affected product and returned to AIC (USA). Customers were instructed that a Aesculap Sales Representative would contact them to schedule return of any affected inventory and replace their product. Customers were asked to complete the inventory sheet with the quantity being returned. If customers could not locate the product, they were to provide an explanation as to why the inventory would not be returned (discarded, etc.). Customers with questions were instructed to call 610-984-9414, For questions regarding this recall call 800-258-1946, ext 5067.
- Quantity
- 14
- Distribution
- Worldwide Distribution - USA including TX, NY, PA, and TN. Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.
- Lot, serial or model codes
- Hi-Line XXS handpiece; Part Number - GB790R , Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GET
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28