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U.S. Department of Health and Human Services

Class 2 Device Recall UHR

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  Class 2 Device Recall UHR see related information
Date Initiated by Firm October 26, 2007
Date Posted March 20, 2008
Recall Status1 Terminated 3 on January 27, 2010
Recall Number Z-0648-2008
Recall Event ID 45854
510(K)Number K800207  
Product Classification Hip Prosthesis Component - Product Code KWL
Product Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Code Information Ref No: Lot Code:  UH1-54-28 5JNMPD UH1-54-28 EDTMND UH1-54-28 HE2MND UH1-54-28 KX6MKD UH1-54-28 LPYMNA UH1-54-28 NARMKD 
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
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

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.
510(K) Database 510(K)s with Product Code = KWL and Original Applicant = OSTEONICS CORP.
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