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U.S. Department of Health and Human Services

Class 2 Device Recall AEQUALIS HUMERAL NAIL DRILL BIT

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  Class 2 Device Recall AEQUALIS HUMERAL NAIL DRILL BIT see related information
Date Initiated by Firm March 26, 2018
Create Date May 09, 2018
Recall Status1 Terminated 3 on August 12, 2021
Recall Number Z-1757-2018
Recall Event ID 79907
510(K)Number K082754  
Product Classification Bit, drill - Product Code HTW
Product AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140

Product Usage:
The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
Code Information Lot numbers:  BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203 
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information Contact Filed Actions
952-683-7482
Manufacturer Reason
for Recall		 Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
FDA Determined
Cause 2		 Package design/selection
Action The firm contacted its distributors by email on 26-March-2018, and a written letter sent 27-March-2018 via FedEx. The Medical Facility was contacted with a written letter sent 28-March-2018 via FedEx.. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the attached Acknowledgement to Wright Medical via email to FieldAction@wright.com. For questions call 952-683-7482.
Quantity in Commerce 3327 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 = HTW and Original Applicant = TORNIER
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