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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer M/L

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  Class 2 Device Recall Zimmer M/L see related information
Date Initiated by Firm February 02, 2006
Date Posted March 21, 2006
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0770-06
Recall Event ID 34634
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
Code Information Lots 08686700 and 08686500.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
FDA Determined
Cause 2		 Other
Action Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products.
Quantity in Commerce 32 right and Left
Distribution Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
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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