| Class 2 Device Recall | |
Date Initiated by Firm | February 11, 2005 |
Date Posted | February 25, 2005 |
Recall Status1 |
Terminated 3 on April 07, 2006 |
Recall Number | Z-0564-05 |
Recall Event ID |
31206 |
Product Classification |
Tourniquet, Pneumatic - Product Code KCY
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Product | Zimmer 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 Contact | Joyce 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 |
Action | Consignees were notified by letter on 02/11/2005. |
Quantity in Commerce | Total 1460 cuffs |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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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