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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 Connectsee related information
Date Initiated by FirmOctober 18, 2019
Create DateDecember 02, 2019
Recall Status1 Terminated 3 on December 14, 2020
Recall NumberZ-0591-2020
Recall Event ID 84177
510(K)NumberK872475 
Product Classification Bur, surgical, general & plastic surgery - Product Code GFF
ProductBRASSELER 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
FEI Number 3004949275
Recalling Firm/
Manufacturer		 Brasseler USA I Lp
1 Brasseler Blvd
Savannah GA 31419-9576
For Additional Information ContactRyan 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
ActionInitial 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 Commerce387 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GFF
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