FDA Medical Device Recalls (openFDA)
Stelkast Co: Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
- Recall number
- Z-0664-2009
- Recalling firm
- Stelkast Co
- Product
- Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
- Status
- Terminated
- Initiated
- 2008-10-07
- Posted
- 2009-01-28
- Terminated
- 2009-04-01
- Reason
- Sterility may be compromised due to breach in packaging.
- Root cause
- Package design/selection
- Action
- On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.
- Quantity
- 6 units
- Distribution
- USA distribution to dealers in TX and WV.
- Lot, serial or model codes
- Part number SC1439-1000. Lot number 17877-071707 exp 7/2017
- 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