Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref… — Class II medical device recall Z-1043-2015
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2015-02-11, distributed nationwide. Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49
| Recall number | Z-1043-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2014-12-15 |
| Classified | 2015-02-03 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2016-09-22 |
| Distributed | Nationwide (US) |
| Lot numbers | 49073501 |
| Model numbers | 540-11-50E |
Product
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
Reason for recall
Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1043-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.