Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall UHR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 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-0623-2008
Recall Event ID 45854
510(K)NumberK800207 
Product Classification Hip Prosthesis Component - Product Code KWL
ProductStryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Code Information Ref No: Description: Lot Code:  UH1-44-28 UHR BIPOLAR 28X44mm 3K4MMD UH1-44-28 UHR BIPOLAR 28X44mm 5P0MLA UH1-44-28 UHR BIPOLAR 28X44mm JEMMNA UH1-44-28 04YMPD UH1-44-28 0YHMMD UH1-44-28 247MMD UH1-44-28 29EMPD UH1-44-28 2HYMRA UH1-44-28 66NMKD UH1-44-28 6W5MPD UH1-44-28 6W6MPD UH1-44-28 8XEMPD UH1-44-28 8XKMPD UH1-44-28 9W0MJA UH1-44-28 D05MKD UH1-44-28 ED8MND UH1-44-28 EP2MPA UH1-44-28 K57MND UH1-44-28 K6LMND UH1-44-28 LA6MPA UH1-44-28 V13MLD UH1-44-28 V17MLD 
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
-
-