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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle

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 Class 2 Device Recall Zimmer Minimally Invasive Solutions Technology Offset Rasp Handlesee related information
Date Initiated by FirmDecember 19, 2008
Date PostedFebruary 27, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall NumberZ-0991-2009
Recall Event ID 50552
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductZimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
Code Information Lot Numbers: 60244767, 60254985, 60270484, 60283990, 60291761, 60295682,60298345, 60327534, 60332316, 60337990, 60347614, 60363922, 60395585, 60406637, 60416986, 60453034, 60468964, 60482887, 60517611, 60688076 and 60810866.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		The c-clip located near the connection end may fracture or fall off during use in surgical procedures.
FDA Determined
Cause 2		Labeling design
ActionU.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce1,461 of both products.
DistributionWorldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.
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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