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Class 2 Device Recall Zimmer |
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Date Initiated by Firm |
June 28, 2007 |
Date Posted |
December 15, 2007 |
Recall Status1 |
Terminated 3 on March 17, 2008 |
Recall Number |
Z-0316-2008 |
Recall Event ID |
38468 |
Product Classification |
Offset Rasp Handle - Product Code LXH
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Product |
Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK |
Code Information |
Lot No: 60646894. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E. Main St. Warsaw IN 46580-2304
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For Additional Information Contact |
574-372-4269
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Manufacturer Reason for Recall |
Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound
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FDA Determined Cause 2 |
Process control |
Action |
Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer. |
Quantity in Commerce |
62 (total for Z-0316-0317-2008) |
Distribution |
Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan. |
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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