FDA Medical Device Recalls (openFDA)
Stelkast Co: Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.
- Recall number
- Z-1073-2009
- Recalling firm
- Stelkast Co
- Product
- Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.
- Status
- Terminated
- Initiated
- 2008-10-31
- Posted
- 2009-03-31
- Terminated
- 2009-04-14
- Reason
- A possible breach of the sterile barrier packaging (Tyvek pouch).
- Root cause
- Packaging
- Action
- The recalling firm telephoned the distributors to inform them of the problem and the need to return the product.
- Quantity
- 187 units
- Distribution
- Nationwide Distribution -- states of NC, TX, and WV.
- Lot, serial or model codes
- Part Number SC1439-0600 - Lot numbers 8257-062904, 14298-0922705, 1740-091007, 14298-092705, 2256-110299, 4844-010302, 5447-072902, 6790-070803, and 8257-062904; Part number SC1439-0700 - Lot numbers 8258-062904, 16935-103006, 17874-061307, 1883-091007, 10559-040105, 16298-042606, 16935-103006, 2257-031199, 4845-101801, 6573-060303, 10559-040105, and 16935-103006; Part number SC1439-0800 - Lot numbers 19636-103006, 17875-043007, 19889-060208, 15910-013006, 16936-103006, 17875-043007, 4048-020701, 4418-071901, 5973-091202, 9776-102704, and 16936-103006; Part number SC1439-0900 - Lot numbers 16937-092506, 16301-042606, 16937-092506, 17876-071707, 10560-040105, 16301-042606, 16937-092506, 3201-110399, 3791-092000, 4617-102401, 6791-070803, 8487-071204, 14989-101205, and 16937-092506; Part number SC1439-1000 - Lot numbers 17610-032207, 14990-101005, 16166-050906, 16166-052206, 16306-082106, 17610-032207, 5260-062702, 7340-011204, and 16306-082106; Part number SC1439-1125 - Lot numbers 16938-092906, 17729-031907, 19152-042908, 20652-101308, 14991-091405, 15913-011806, 16439-050406, 16938-092906, 17729-031907, 2261-110299, 6113-111102, 6177-010703, 7341-090203, 15913-011806, and 17729-031907; Part number SC1439-1250 - Lot numbers 16839-082106, 8003-052504, 16939-102306, 17730-031907, 10563-040505, 15911-013006, 16839-082106, 16939-102306, 4420-1000901, 5006-040402, 6793-060303, 8003-052504, 16839-082106, and 16939-102306; Part number SC1439-1375 - Lot numbers 17731-031907, 17731-031907, 20654-092208, 10172-120604, 10564-041205, 14993-092605, 15912-013006, 17731-031907, 3794-121300, 15912-013006, and 17731-031907; Part number SC1439 - Lot numbers 8025-052504, 19153-042908, 14299-092705, 1889-110299, 19153-042908, 5262-050202, 6306-021803, 8025-052504, 5262-050202, and 8025-052504; Part number SC1439-1625 - Lot numbers 1749-110299, 17120-022707, 1749-032007, 1749-110299, 2265-091499, 17120-022707, and 1749-110299; Part number SC1439-1750 - Lot numbers 1750-110299, 1169-091007, 1169-120406, 1649-030707, 1649-081307, 1649-091007, 1750-091007, and 1750-110299.
- 510(k) numbers
- ["K953268"]
- PMA numbers
- not on file
- Product code
- LWJ
- Firm FEI
- 3004142400
- Firm city
- Mcmurray
- Firm state
- PA
- 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