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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-0388-05
Recall Event ID 30476
Product Classification Tourniquet, Pneumatic - Product Code KCY
ProductZimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single 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 #60-7075-007-00, Lot #60171355. On 02/11/2005 the firm expanded the recall to include all cuffs including the following codes:Cat #60-7075-006-00, Lot #60154126, Single Port Cuff Cat #60-7075-056-00, Lot #60135939, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-004-00, Lot #60144536, Single Port Cuff, Cat #60-7075-007-00, Lot #60156860, Single Port Cuff, Cat #60-7075-052-00, Lot #60121031, Single Port Cuff, Cat #60-7075-001-00, Lot #60132141, Single Port Cuff, Cat #60-7075-003-00, Lot #60175349, Single Port Cuff, Cat #60-7075-006-00, Lot #60168614, Single Port Cuff, Cat #60-7075-003-00, Lot #60180950, Single Port Cuff, Cat #60-7075-006-00, Lot #60180452, Single Port Cuff, Cat #60-7075-054-00, Lot #60129625, Single Port Cuff, Cat #60-7075-004-00, Lot #60162833, Single Port Cuff, Cat #60-7075-007-00, Lot #60184637, Single Port Cuff, Cat #60-7075-006-00, Lot #60191899, Single Port Cuff, Cat #60-7075-053-00, Lot #60155642, Single Port Cuff, Cat #60-7075-005-00, Lot #60173812, Single Port Cuff, Cat #60-7075-001-00, Lot #60176467, Single Port Cuff, Cat #60-7070-003-00, Lot #60191898, Single Port Cuff, Cat #60-7075-003-00, Lot #60205584, Single Port Cuff, Cat #60-7075-003-00, Lot #60210874, Single Port Cuff, Cat #60-7075-006-00, Lot #60202395, Single Port Cuff, Cat #60-7075-056-00, Lot #60172186, Single Port Cuff, Cat #60-7075-053-00, Lot #60162834, Single Port Cuff, Cat #60-7075-054-00, Lot #60189989, Single Port Cuff, and Cat #60-7075-002-00, Lot #60180458, Single Port Cuff. 
FEI Number 1035617
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 53100 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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