| Class 2 Device Recall Bipolar Cap | |
Date Initiated by Firm | February 20, 2013 |
Date Posted | May 24, 2013 |
Recall Status1 |
Terminated 3 on March 26, 2014 |
Recall Number | Z-1383-2013 |
Recall Event ID |
64588 |
510(K)Number | K101670 |
Product Classification |
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
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Product | Bipolar Cap, ID26mm, OD42mm
Bipolar Cap, ID28mm, OD44mm
Bipolar Cap, ID28mm, OD46mm
Bipolar Cap, ID28mm, OD48mm
Bipolar Cap, ID28mm, OD50mm
Bipolar Cap, ID28mm, OD52mm
Bipolar Cap, ID28mm, OD54mm
Bipolar Cap, ID28mm, OD56mm |
Code Information |
Item No. 1503-3042 1503-3144 1503-3146 1503-3148 1503-3150 1503-3152 1503-3154 1503-3156 |
Recalling Firm/ Manufacturer |
Orthopedic Alliance LLC 26157 Jefferson Ave Murrieta CA 92562-9561
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For Additional Information Contact | 909-304-9001 |
Manufacturer Reason for Recall | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery. |
FDA Determined Cause 2 | Labeling design |
Action | A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature. |
Quantity in Commerce | 37 units |
Distribution | Nationwide Distribution including the states of CA, MD, TX, NV, and WI. |
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 = KWY
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