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U.S. Department of Health and Human Services

Class 2 Device Recall MaxLock Extreme ModFoot Concave Reamer

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  Class 2 Device Recall MaxLock Extreme ModFoot Concave Reamer see related information
Date Initiated by Firm September 19, 2014
Date Posted October 10, 2014
Recall Status1 Terminated 3 on October 31, 2016
Recall Number Z-0062-2015
Recall Event ID 69294
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside.

Used during procedures to clear away bone and cartilage within the desired implant area.
Code Information Part Number: MFT-074-CC-24; Lot: 3164011
Recalling Firm/
Manufacturer		 Orthohelix Surgical Designs Inc
1065 Medina Rd Ste 500
Medina OH 44256-5376
For Additional Information Contact
330-869-9582
Manufacturer Reason
for Recall		 Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
FDA Determined
Cause 2		 Device Design
Action An Urgent - Medical Device Recall customer notification, dated September 19, 2014, was sent out via email and FEDEx to all distributors with instructions on returning the product. The letter identified the affected product and the reason for the recall. Customers are to immediately cease distribution of the affected product, and complete and return the questionnaire. The letter also states that the recalled product will be replaced. Questions are to be directed to the Customer Service Department 1-888-494-7950.
Quantity in Commerce 38
Distribution USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
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.
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