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Class 2 Device Recall Femoral head |
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Date Initiated by Firm |
February 20, 2013 |
Date Posted |
May 24, 2013 |
Recall Status1 |
Terminated 3 on March 26, 2014 |
Recall Number |
Z-1382-2013 |
Recall Event ID |
64588 |
510(K)Number |
K111546
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Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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Product |
Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femoral head, ¿32mm, +0mm Femoral head, ¿32mm, +5mm Femoral head, ¿32mm, +10mm Femoral head, ¿36mm, -3mm Femoral head, ¿36mm, +0mm Femoral head, ¿36mm, +5mm Femoral head, ¿36mm, +10mm
Variety of hip and knee implants and instruments, multiple uses.
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Code Information |
Item No. 1201-1126 1201-1326 1201-1526 1201-1726 1201-1028 1201-1128 1201-1428 1201-1828 1201-1032 1201-1132 1201-1432 1201-1832 1201-1036 1201-1136 1201-1436 1201-1836 |
Recalling Firm/ Manufacturer |
Orthopedic Alliance LLC 26157 Jefferson Ave Murrieta CA 92562-9561
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For Additional Information Contact |
909-304-9001
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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.
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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 |
21 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 = LPH and Original Applicant = UNITED ORTHOPEDIC CORP.
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