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U.S. Department of Health and Human Services

Class 2 Device Recall BRASSELER Twist Drill Quick Connect

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  Class 2 Device Recall BRASSELER Twist Drill Quick Connect see related information
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
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