Recall Z-0591-2020— Brasseler USA I Lp

Name: FDA recall Z-0591-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-18

Class II · Terminated

Class II FDA medical device recall by Brasseler USA I Lp, initiated 2019-10-18, terminated 2020-12-14. It names one FDA 510(k) clearance: K872475. 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.. Reason: One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device..

Recalling firm: Brasseler USA I Lp
Classification: Class II
Status: Terminated
Initiated: 2019-10-18
Terminated: 2020-12-14
Firm location: Savannah, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K872475 — SURGICAL BURTava Surgical Instruments·cleared 1987-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.

Data sourced from openFDA. This site is unofficial and independent of the FDA.