FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Trident Hemispherical Acetabular Shells HA Solid BK 42mm- 74mm; Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
- Recall number
- Z-1169-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Trident Hemispherical Acetabular Shells HA Solid BK 42mm- 74mm; Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
- Status
- Terminated
- Initiated
- 2008-01-21
- Posted
- 2008-06-12
- Terminated
- 2012-09-25
- Reason
- Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Root cause
- Process design
- Action
- Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.
- Quantity
- 129,312 total shells, all Trident hemispherical types
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Catalog Number s: 500-11-42A, 42mm; 500-11-44B, 44mm; 500-11-46C, 46mm; 500-11-48D, 48mm; 500-11-50D, 50mm; 500-11-52E, 52mm; 500-11-54E, 54mm; 500-11-56F, 56mm; 500-11-58-F, 58mm; 500-11-60G, 60mm; 500-11-62G, 62mm; 500-11-64H, 64mm; 500-11-66H, 66mm; 500-11-681, 68mm; 500-11-701, 70mm; 500-11-72J, 72mm; 500-11-74J, 74mm. All lot codes with expiration dates between 1/2005 and 12/2012.
- 510(k) numbers
- ["K013676"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28