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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer MIS

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 Class 2 Device Recall Zimmer MISsee related information
Date Initiated by FirmFebruary 02, 2006
Date PostedMarch 21, 2006
Recall Status1 Terminated 3 on December 05, 2007
Recall NumberZ-0672-06
Recall Event ID 34634
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
ProductZimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
Code Information Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
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
ActionFirm 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 Commerce495 Right and Left
DistributionNationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
Total Product Life CycleTPLC 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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