FDA Medical Device Recalls (openFDA)
Stelkast Co: StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, StelKast, Murray, PA 15317
- Recall number
- Z-0480-2008
- Recalling firm
- Stelkast Co
- Product
- StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, StelKast, Murray, PA 15317
- Status
- Terminated
- Initiated
- 2007-10-05
- Posted
- 2008-01-23
- Terminated
- 2008-01-23
- Reason
- The screws may fracture
- Root cause
- Device Design
- Action
- The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.
- Quantity
- 38 units
- Distribution
- Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
- Lot, serial or model codes
- Lot Numbers: 14890-111605, 17084-110706, and 17942-091807.
- 510(k) numbers
- ["K051976"]
- PMA numbers
- not on file
- Product code
- JWH
- 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