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U.S. Department of Health and Human Services

Class 2 Device Recall Greatbatch Double Offset Rasp Handle, Left Hand

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 Class 2 Device Recall Greatbatch Double Offset Rasp Handle, Left Handsee related information
Date Initiated by FirmJuly 23, 2014
Date PostedAugust 14, 2014
Recall Status1 Terminated 3 on September 15, 2015
Recall NumberZ-2226-2014
Recall Event ID 68656
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductDouble Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
Code Information Item Number 00780803521  Lot Number 56474891, 56474892, 56474893, 56474894                  
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactConsumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
FDA Determined
Cause 2		Device Design
ActionOn July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.
Quantity in Commerce412 units
DistributionWorldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
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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