Z-0591-2020Class II

BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm -

Name: Z-0591-2020 BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm -
Creator: Brasseler USA I Lp
Published: 2019-10-18
License: https://open.fda.gov/license/

Brasseler USA I, L.P. / initiated 2019-10-18 / Terminated

FDA source

Brasseler USA I Lp began a recall of 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... on 2019-10-18. FDA classified it as Class II and gives the reason as "One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0591-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-18
Posted: 2019-12-02
Terminated: 2020-12-14
Recalling firm: Brasseler USA I, L.P.
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.
Product code: GFF Bur, Surgical, General & Plastic Surgery
Reason for recall: One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
FDA 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 in commerce: 387 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number NR1VM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0591-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0591-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-02

Product code GFF

K872475Class ISurgical BurTava Surgical Instruments / cleared 1987-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)