| Class 2 Device Recall UHR | |
Date Initiated by Firm | October 26, 2007 |
Date Posted | March 20, 2008 |
Recall Status1 |
Terminated 3 on January 27, 2010 |
Recall Number | Z-0635-2008 |
Recall Event ID |
45854 |
510(K)Number | K800207 |
Product Classification |
Hip Prosthesis Component - Product Code KWL
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Product | Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 |
Code Information |
Ref No: Description: Lot Code: UH1-50-26 UHR BIPOLAR 26X50mm 6X5MAD UH1-50-26 UHR BIPOLAR 26X50mm J3VMKA UH1-50-26 UHR BIPOLAR 26X50mm J84MDA UH1-50-26 KJ1MEA UH1-50-26 KJ4MEA UH1-50-26 KJ8MEA UH1-50-26 KJ9MEA UH1-50-26 KJAMEA |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
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For Additional Information Contact | Rita Intorella 201-831-5825 |
Manufacturer Reason for Recall | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
FDA Determined Cause 2 | Process control |
Action | Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007. |
Quantity in Commerce | 360 total |
Distribution | Worldwide Distribution - USA, Canada,
China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England. |
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 = KWL
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