| Class 2 Device Recall UJoint Hex Head Driver | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LZO
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