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 Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cup

  • 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 Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cupsee related information
Date Initiated by FirmJuly 12, 2007
Date PostedOctober 25, 2007
Recall Status1 Terminated 3 on February 02, 2010
Recall NumberZ-0023-2008
Recall Event ID 39402
PMA NumberP040033 
Product Classification Hip implant acetabular component. - Product Code LXH
ProductSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component.
Code Information Lot Numbers: 64767, 65679, 65943, 63452, 64595, 64800, 64840, 64841, 64856, 64858, 65004, 65005, 65075, 65078, 65080, 65082, 65478, 65529, 65533, 65942, 65946, 66109, 66131, 66621, 66878, 67220, 67346
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information ContactVictor Rocha
901-399-6771
Manufacturer Reason
for Recall		The carton label may not reflect the correct size of the acetabular cup.
FDA Determined
Cause 2		Packaging process control
ActionThe consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007.
Quantity in Commerce42 units
DistributionWorldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
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.
-
-