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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 UHRsee related information
Date Initiated by FirmOctober 26, 2007
Date PostedMarch 20, 2008
Recall Status1 Terminated 3 on January 27, 2010
Recall NumberZ-0636-2008
Recall Event ID 45854
510(K)NumberK800207 
Product Classification Hip Prosthesis Component - Product Code KWL
ProductStryker Orthopaedics; UHR Universal Bipolar Component; 28 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Code Information Ref No: Description: Lot Code:  UH1-50-28 UHR BIPOLAR 28X50mm 0L7MHD UH1-50-28 UHR BIPOLAR 28X50mm 3JDMKA UH1-50-28 UHR BIPOLAR 28X50mm N4NMRA UH1-50-28 1E6MEA UH1-50-28 1EEMPD UH1-50-28 4E4MMD UH1-50-28 685MTA UH1-50-28 6W9MPD UH1-50-28 805MPD UH1-50-28 8HMMJA UH1-50-28 8XNMPD UH1-50-28 E9EMPD UH1-50-28 EKPMEA UH1-50-28 HHYMDA UH1-50-28 HLEMEA UH1-50-28 K5AMND 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactRita 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
ActionStryker 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 Commerce360 total
DistributionWorldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KWL
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