| Class 2 Device Recall Zimmer Femoral Stem |  |
Date Initiated by Firm | May 15, 2009 |
Date Posted | July 06, 2009 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number | Z-1615-2009 |
Recall Event ID |
52128 |
510(K)Number | K992667 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Product Code LWJ
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Product | Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18.
Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics. |
Code Information |
Lot Number: 60698102. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | 800-613-6131 |
Manufacturer Reason for Recall | The threads on the screw are incomplete/non-functional. |
FDA Determined Cause 2 | Process control |
Action | Zimmer, Inc. began Consignee notification of the affected device via telephone on May 15, 2009. A certified "Urgent: Device Recall" notification dated May 21, 2009 was sent to all consignees instructing them of the affected device, to stop use of and return it with a Return Certification form. The Return Verification form should also be faxed to Zimmer, Inc. at 1-574-372-4265.
For shipping assistance, questions or other concerns, contact Zimmer, Inc. at 1-800-613-6131. |
Quantity in Commerce | 10 |
Distribution | Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia. |
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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510(K) Database | 510(K)s with Product Code = LWJ
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