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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 FirmOctober 27, 2004
Date PostedJanuary 12, 2005
Recall Status1 Terminated 3 on December 20, 2005
Recall NumberZ-0390-05
Recall Event ID 30476
Product Classification Tourniquet, Pneumatic - Product Code KCY
ProductZimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Dual Port, Single Bladder 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 #60-7070-002-00, Lot #60156865. On 02/11/2005 the firm expanded the recall to include the following codes:  Cat #60-7070-003-00, Lot #60154121, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60166017, Dual Port Single, Bladder Cuff, Cat #60-7070-007-00, Lot #60135936, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60162824, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60161308, Dual Port Single, Bladder Cuff, Cat #60-7070-001-00, Lot #60159350, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60173808, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60171347, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60171346, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60191896, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60180450, Dual Port Single, Bladder Cuff, Cat #60-7070-007-00, Lot #60162831, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60184634, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60173807, Dual Port Single, Bladder Cuff, Cat #60-7070-003-00, Lot #60194151, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60194152, Dual Port Single, Bladder Cuff, Cat #60-7070-004-00, Lot #60188441, Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60202399, Dual Port Single, Bladder Cuff, Cat #60-7070-001-00, Lot #60176464, Dual Port Single, Bladder Cuff, Cat 360-7070-003-00, Lot #60205580, Dual Port Single, Bladder Cuff, Cat #60-7070-006-00, Lot #60208192, Dual Port Single, Bladder Cuff, Cat #60-7070-002-00, Lot #60187086. Dual Port Single, Bladder Cuff, Cat #60-7070-005-00, Lot #60178439, Dual Port, Single Bladder Cuff, 
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 first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.
Quantity in CommerceTotal 45730 cuffs
DistributionNationwide, Australia, Demark, Germany
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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