| Class 2 Device Recall Proximal Tibial Spacer | |
Date Initiated by Firm | February 01, 2013 |
Date Posted | March 15, 2013 |
Recall Status1 |
Terminated 3 on September 22, 2014 |
Recall Number | Z-0953-2013 |
Recall Event ID |
64465 |
510(K)Number | K071738 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508. |
Code Information |
Catalog # 02-012-42-3508 All lot numbers |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact | 352-377-1140 |
Manufacturer Reason for Recall | A dimensional mismatch was identified which can potentially allow for interference between devices. |
FDA Determined Cause 2 | Device Design |
Action | Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1. Customers were instructed to immediately cease distribution or use of these products.
2. Extend this information to your accounts that may have this product in their possession.
3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots.
Please complete the attached fax back form and return it to Exactech within the next 5 working days. Thank you for your prompt attention to this matter.
For further questions please call (352) 377-1140. |
Quantity in Commerce | 123 devices |
Distribution | Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico. |
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 = JWH
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