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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer/CAS Power Cord, Sesamoid Plasty, NA

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 Class 2 Device Recall Zimmer/CAS Power Cord, Sesamoid Plasty, NAsee related information
Date Initiated by FirmNovember 02, 2009
Date PostedDecember 22, 2009
Recall Status1 Terminated 3 on October 15, 2010
Recall NumberZ-0558-2010
Recall Event ID 53687
510(K)NumberK060336 K071714 K071929 
Product Classification power cord - Product Code HAW
ProductZimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.
Code Information Workstation serial numbers SP014, SP015, SP019 through SP022, SP025 through SP033, SP035, SP038, SP039, SP043, SP044, SP047, SP049, SP052, SP057, SP058, SP060, SP061, SP062, SP064, SP065, SP069, SP072, SP074 through SP083, SP089, SP090, SP091, SP093, SP094, SP098, SP099, SP121, SP124, SP125, SP127, SP128, SP131 through SP135, SP151 through SP154, SP157, SP175, SP176, SP183, SP184, SP185, SP190 and SP198.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
866-978-3801
Manufacturer Reason
for Recall		The power cord female receptacle is not recessed sufficiently and may present a shock hazard.
FDA Determined
Cause 2		Device Design
ActionZimmer sales staff were notified by letter dated 11/2/09 and instructed to locate the units and to upgrade the cords and to notify consignees by copy of a letter addressed to risk managers and dated 11/2/09.
Quantity in Commerce71
DistributionNationwide.
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.
510(K) Database510(K)s with Product Code = HAW
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