| Date Initiated by Firm | October 27, 2004 |
|---|
| Date Posted | January 12, 2005 |
|---|
| Recall Status1 |
Terminated 3 on December 20, 2005 |
| Recall Number | Z-0389-05 |
|---|
| Recall Event ID |
30476 |
| Product Classification |
Tourniquet, Pneumatic - Product Code KCY
|
| Product | Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), 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 #60-7075-002-00, Lot #60153745 |
| FEI Number |
1035617
|
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 first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004. |
|---|
| Quantity in Commerce | 42 units (10 cuffs per unit) |
|---|
| Distribution | Nationwide, Australia, Demark, Germany |
|---|
| Total Product Life Cycle | TPLC 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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