FDA Medical Device Recalls (openFDA)
Brasseler USA I Lp: BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
- Recall number
- Z-0591-2020
- Recalling firm
- Brasseler USA I Lp
- Product
- BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
- Status
- Terminated
- Initiated
- 2019-10-18
- Posted
- not on file
- Terminated
- 2020-12-14
- Reason
- One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
- Root cause
- Under Investigation by firm
- Action
- Initial contact to customers was by telephone and visit on 18 October 2019. The firm followed with a letter disseminated by email on 10/25/2019. The firm is seeking return of the affected units and will replace them with correct devices.
- Quantity
- 387 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Number NR1VM
- 510(k) numbers
- ["K872475"]
- PMA numbers
- not on file
- Product code
- GFF
- Firm FEI
- 3004949275
- Firm city
- Savannah
- Firm state
- GA
- 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