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U.S. Department of Health and Human Services

Class 2 Device Recall Trident PSL

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  Class 2 Device Recall Trident PSL 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-0072-2008
Recall Event ID 44780
510(K)Number K983382  
Product Classification Hip prosthesis acetabular component - Product Code MEH
Product Trident PSL HA Cluster Acetabular Shell;
Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component.
Howmedica Osteonics Corp.
325 Corporate Drive;
Mahwah, NJ 07430;
A subsidiary of Stryker Corp.
Sterile, Made in USA.
Code Information Catalog # Description Lot code 542-11-46D TRIDENT PSL HA CLUSTER 46mm R3YMHD; 542-11-48D TRIDENT PSL HA CLUSTER 48mm 1PMMJD 542-11-48D TRIDENT PSL HA CLUSTER 48mm 663MJD 542-11-48D TRIDENT PSL HA CLUSTER 48mm 664MJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 1TEMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 1TJMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 2K0MJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 32JMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 61YMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 626MJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 70HMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 71NMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm PYNMHD 542-11-50E TRIDENT PSL HA CLUSTER 50mm RHVMHD 542-11-50E TRIDENT PSL HA CLUSTER 50mm RHXMHD 542-11-52E TRIDENT PSL HA CLUSTER 52mm 8R8MJD 542-11-52E TRIDENT PSL HA CLUSTER 52mm 8RDMJD 542-11-52E TRIDENT PSL HA CLUSTER 52mm PYVMHD 542-11-52E TRIDENT PSL HA CLUSTER 52mm REKMHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 0YPMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 3HAMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 500MJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 76YMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 7NWMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 7Y3MJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 7Y4MJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 8HWMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm TK9MHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm TKAMHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm TKDMHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm TKEMHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm TKHMHD 542-11-56F TRIDENT PSL HA CLUSTER 56mm 0PJMJD 542-11-56F TRIDENT PSL HA CLUSTER 56mm 0PMMJD 542-11-56F TRIDENT PSL HA CLUSTER 56mm 81AMJD 542-11-56F TRIDENT PSL HA CLUSTER 56mm 81DMJD 542-11-56F TRIDENT PSL HA CLUSTER 56mm T6KMHD 542-11-58G TRIDENT PSL HA CLUSTER 58mm 518MJD 542-11-62H TRIDENT PSL HA CLUSTER 62mm 2PMMJD 542-11-62H TRIDENT PSL HA CLUSTER 62mm 7D2MJD 542-11-68I TRIDENT PSL HA CLUSTER 68mm 3AWMJD 542-11-72J TRIDENT PSL HA CLUSTER 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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