Z-0072-2008

Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis...

Name: Z-0072-2008 Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-08-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-08-30 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive... on 2007-08-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0072-2008
Status: Terminated
Initiated: 2007-08-30
Posted: 2007-10-25
Terminated: 2008-09-05
Recalling firm: Howmedica Osteonics Corp
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.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Product code MEH

K983382Class IIOsteonics Ha Generation II Acetabular Component SystemOsteonics Corp. / cleared 1998-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)