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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-0625-2008
Recall Event ID 45854
510(K)NumberK800207 
Product Classification Hip Prosthesis Component - Product Code KWL
ProductStryker Orthopaedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Code Information Ref No: Description: Lot Code:  UH1-45-28 UHR BIPOLAR 28X45mm 6AWMNA UH1-45-28 UHR BIPOLAR 28X45mm 88LMNA UH1-45-28 UHR BIPOLAR 28X45mm V1RMLD UH1-45-28 0YMMMD UH1-45-28 3KKMMD UH1-45-28 4JJMPD UH1-45-28 6W7MPD UH1-45-28 8XLMPD UH1-45-28 DTEMND UH1-45-28 EHRMKA UH1-45-28 L96MPA UH1-45-28 PM5MEA UH1-45-28 PM7MEA UH1-45-28 V1LMLD UH1-45-28 V1MMLD UH1-45-28 V1NMLD UH1-45-28 V1TMLD 
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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