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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 Pinsee related information
Date Initiated by FirmDecember 11, 2019
Create DateJanuary 29, 2020
Recall Status1 Terminated 3 on February 12, 2021
Recall NumberZ-0884-2020
Recall Event ID 84545
510(K)NumberK945670 
Product Classification Pin, fixation, smooth - Product Code HTY
ProductBrasseler 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
FEI Number 3004949275
Recalling Firm/
Manufacturer		 Brasseler USA I Lp
1 Brasseler Blvd
Savannah GA 31419-9576
For Additional Information ContactRyan 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
ActionInitial 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 Commerce56 packs of 6
DistributionUS: AZ, AR, FL
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 = HTY
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