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U.S. Department of Health and Human Services

Class 2 Device Recall HA Generation II

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  Class 2 Device Recall HA Generation II see related information
Date Initiated by Firm August 30, 2007
Date Posted October 25, 2007
Recall Status1 Terminated 3 on September 05, 2008
Recall Number Z-0073-2008
Recall Event ID 44780
510(K)Number K983382  
Product Classification Hip prosthesis acetabular component - Product Code MEH
Product HA Solid Back Acetabular Shell;
Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component.
Sterile; made in USA;
Howmedica Osteonics Corp.;
325 Corporate Drive;
Mahwah, NJ 07430
A Subsidiary of Stryker Corp.
Code Information 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 8NKMJD 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 3H7MJD 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 78AMJD 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 9T9MJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4THMJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4TJMJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm RLKMHD 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 1WNMJD
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact
201-831-5000
Manufacturer Reason
for Recall		 Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.
FDA Determined
Cause 2		 Process control
Action Recall notification letters were sent out on August 30, 2007 with return receipt.
Quantity in Commerce 142 units
Distribution Product was distributed nationwide and one unit to Brazil.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MEH and Original Applicant = OSTEONICS CORP.
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