HA Solid Back Acetabular Shell recallZ-0073-2008 · 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-0073-2008
- 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
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.
Code information (models, lots, serial numbers)
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
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-0072-2008 · TerminatedTrident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah, NJ 07430; …
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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