Trident PSL HA Cluster Acetabular Shell recallZ-0072-2008 · Stryker Howmedica Osteonics Corp. · initiated Aug 30, 2007
Terminated All recalls posted in October 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
Recall notification letters were sent out on August 30, 2007 with return receipt.
Recall details
- Recall number
- Z-0072-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 30, 2007
- Posted by the FDA
- Oct 25, 2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 142 units
- Product code
- MEH
- FDA submissions
- K983382
- Distribution
- Product was distributed nationwide and one unit to Brazil.
Product description
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 (models, lots, serial numbers)
Show the full code information (2k characters)
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
Other devices under the same FDA submission
9 devices cleared under K983382 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Trident 621-00-28EHowmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Trident 621-00-28GHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Trident 621-00-28IHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Trident 621-10-26EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Trident 621-10-26DHowmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trident 621-10-26FHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Trident 621-10-28EHowmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trident 621-10-28FHowmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trident 621-10-28GHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 44780).
- Z-0073-2008 · TerminatedHA 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; M…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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