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U.S. Department of Health and Human Services

Class 2 Device Recall Brasseler USA Steinmann Pin

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  Class 2 Device Recall Brasseler USA Steinmann Pin see related information
Date Initiated by Firm December 11, 2019
Create Date January 29, 2020
Recall Status1 Terminated 3 on February 12, 2021
Recall Number Z-0884-2020
Recall Event ID 84545
510(K)Number K945670  
Product Classification Pin, fixation, smooth - Product Code HTY
Product Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm

Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
Code Information Lot Number NR8ZR
Recalling Firm/
Manufacturer		 Brasseler USA I Lp
1 Brasseler Blvd
Savannah GA 31419-9576
For Additional Information Contact Ryan Dew
912-921-7519
Manufacturer Reason
for Recall		 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.
FDA Determined
Cause 2		 Labeling mix-ups
Action Initial contact to affected consignees was made on 12/11/2019 by telephone to provide notification of the labeling error and arrange for replacement product. Recall letter also sent to affected consignees.
Quantity in Commerce 56 packs of 6
Distribution US: AZ, AR, FL
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 = HTY and Original Applicant = BRASSELER USA I, L.P.
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