Date Initiated by Firm |
October 18, 2019 |
Create Date |
December 02, 2019 |
Recall Status1 |
Terminated 3 on December 14, 2020 |
Recall Number |
Z-0591-2020 |
Recall Event ID |
84177 |
510(K)Number |
K872475
|
Product Classification |
Bur, surgical, general & plastic surgery - Product Code GFF
|
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. |
Code Information |
Lot Number NR1VM |
Recalling Firm/ Manufacturer |
Brasseler USA I Lp 1 Brasseler Blvd Savannah GA 31419-9576
|
For Additional Information Contact |
Ryan Dew 912-925-7519
|
Manufacturer 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 Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GFF and Original Applicant = TAVA SURGICAL INSTRUMENTS
|