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U.S. Department of Health and Human Services

Class 2 Device Recall UJoint Hex Head Driver

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  Class 2 Device Recall UJoint Hex Head Driver see related information
Date Initiated by Firm December 19, 2011
Date Posted January 13, 2012
Recall Status1 Terminated 3 on August 27, 2012
Recall Number Z-0740-2012
Recall Event ID 60722
510(K)Number K103384  
Product Classification Prothesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit.

The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum.
Code Information Lot numbers 1365304, 1365305.
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 Business Park Dr
Draper UT 84020-8663
For Additional Information Contact
801-619-3450
Manufacturer Reason
for Recall		 Tip of hex-head screwdriver may break off during use in hip replacement procedure.
FDA Determined
Cause 2		 Device Design
Action Ortho Development Corporation sent an "URGENT!! DEVICE RECALL" letter dated December 19, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check to see if they have the affected device. Customers who have the device are to return the device to the firm, immediately. The firm will provide suitable replacements. Contact the Regulatory Affairs Manager for questions regarding this notice.
Quantity in Commerce 37 units
Distribution Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.
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 = LZO and Original Applicant = ORTHO DEVELOPMENT
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