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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 24, 2005
Date PostedNovember 01, 2005
Recall Status1 Terminated 3 on April 05, 2006
Recall NumberZ-0106-06
Recall Event ID 33361
510(K)NumberK940307 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish - Product Code MAY
ProductMeridian PA Femoral Stem
Code Information Catalog No --Description -- # of Lots: 6261-0-001, Meridian PA Hip Stem #00/9, 25 lots; 6261-0-002, Meridian PA Hip Stem #00/10, 26 lots; 6261-0-003, Meridian PA Hip Stem #1/11MM, 107 lots; 6261-0-004, Meridian PA Hip Stem #2/10MM, 16 lots; 6261-0-005, Meridian PA Hip Stem #2/12MM, 109 lots; 6261-0-006, Meridian PA Hip Stem #3/11MM 150 lots; 6261-0-007, Meridian PA Hip Stem #3/13MM, 256 lots; 6261-0-008, Meridian PA Hip Stem #4/12MM, 115 lots; 6261-0-009, Meridian PA Hip Stem #4/14MM, 194 lots; 6261-0-010, Meridian PA Hip Stem #5/13MM, 139 lots; 6261-0-011, Meridian PA Hip Stem #5/15MM, 104 lots; 6261-0-012, Meridian PA Hip Stem #6/14MM, 96 lots; 6261-0-013, Meridian PA Hip Stem, #6/16MM, 73 lots; 6261-0-014, Meridian PA Hip Stem, #7/15MM, 21 lots; 6261-0-015, Meridian PA Hip Stem, #7/17MM, 25 lots; 6261-0-016, Meridian PA Hip Stem, #8/16, 16 lots; 6261-0-017, Meridian PA Hip Stem, #8/18, 15 lots;    
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactDominick Cristofolo
201-831 Ext. 5247
Manufacturer Reason
for Recall		The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
FDA Determined
Cause 2		Other
ActionA urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.
Quantity in Commerce1936 units
Distributionnationwide
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 = MAY
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