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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 11, 2005
Date PostedFebruary 25, 2005
Recall Status1 Terminated 3 on April 07, 2006
Recall NumberZ-0564-05
Recall Event ID 31206
Product Classification Tourniquet, Pneumatic - Product Code KCY
ProductZimmer Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.
Code Information Cat #60-7080-002-00, Lot #60135943,  Cat #60-7080-003-00, Lot #60108064, and Cat #60-7080-002-00, Lot #60162837.
Recalling Firm/
Manufacturer
Zimmer Orthopaedic Surgical Products
2021 Old Mountain Rd
Statesville NC 28625-1630
For Additional Information ContactJoyce Elkins
330-364-9483
Manufacturer Reason
for Recall
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
FDA Determined
Cause 2
Other
ActionConsignees were notified by letter on 02/11/2005.
Quantity in CommerceTotal 1460 cuffs
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.
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