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U.S. Department of Health and Human Services

Class 3 Device Recall Exactech

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  Class 3 Device Recall Exactech see related information
Date Initiated by Firm August 01, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-1211-03
Recall Event ID 26919
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.
Code Information Tibial Augment block Trial, Catalog # 205-60-05, Lot #''s 4786-001 and 6509-001 Tibial Augment Block Trial, Catalog # 205-60-08 Lot #''s 4786-002 and 6509-002 Tibial Tray Trial, Catalog # 201-70-81, Lot #''s 4580-002, 6449-002 & 09861014 Trapezoid Tray Trial, Catalog # 205-70-81, Lot #''s 4603-002 & 6449-013
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 N.W. 66th Court
Gainesville FL 32653
For Additional Information Contact Karen Norman
800-392-2832
Manufacturer Reason
for Recall
Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used.
FDA Determined
Cause 2
Other
Action A recall letter dated July 31, 2003, requesting return of certain Tibial Augmentation Block Trials and an advisory (Field Advisory K-078) on the use of certain Tibial Tray Trials and Trapezoid Tibial Tray Trials. The recall letter gives the address to return product as: Exactech, 2243 NW 66th Court, Gainesville, FL. Consignees were told to immediately cease distribution or use of the recalled products and to return them. Also the letter asks them to extend the recall information to their user accounts and to read and comply with the instructions provided in the attached 'Field Advisory K-078'. This advisory instructs the dealers and users on the use of the devices to avoid problems.
Quantity in Commerce 169
Distribution Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.
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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