—#64356

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.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K983382
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

Recall notification letters were sent out on August 30, 2007 with return receipt.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Product was distributed nationwide and one unit to Brazil.

Timeline

Recall initiated: 2007-08-30
Posted by FDA: 2007-10-25
Terminated: 2008-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64356. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.