| | Class 2 Device Recall |  |
| Date Initiated by Firm | February 11, 2005 |
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| Date Posted | February 25, 2005 |
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| Recall Status1 |
Terminated 3 on April 07, 2006 |
| Recall Number | Z-0565-05 |
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| Recall Event ID |
31206 |
| Product Classification |
Tourniquet, Pneumatic - Product Code KCY
|
| Product | Zimmer Orthopaedic Surgical Products, Disposable Cuff, Single 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 #60-7085-003-00, Lot #60116761, and Cat #60-7085-002-00, Lot #60149051. |
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. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified by letter on 02/11/2005. |
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| Quantity in Commerce | Total 430 cuffs |
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| Distribution | Nationwide |
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| 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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