Z-0073-2008

HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component...

Name: Z-0073-2008 HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component...
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 HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. Sterile; made in USA; Howmedica Osteonics Corp.; 325... 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-0073-2008
Status: Terminated
Initiated: 2007-08-30
Posted: 2007-10-25
Terminated: 2008-09-05
Recalling firm: Howmedica Osteonics Corp
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.
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: 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

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)