FDA Medical Device Recalls (openFDA)
Stelkast Co: SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
- Recall number
- Z-2136-2013
- Recalling firm
- Stelkast Co
- Product
- SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
- Status
- Terminated
- Initiated
- 2013-06-24
- Posted
- 2013-09-03
- Terminated
- 2014-10-08
- Reason
- The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
- Root cause
- Process control
- Action
- Stelkast called and emailed all customers on June 24, 2013, to notify them of the recall. Customers were asked to recover all affected products from their inventory and return them to Stelkast. Customers were instructed to contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast. Customers with questions were instructed to call 1-888-273-1583. For questions regarding this recall call 724-941-6368.
- Quantity
- 11
- Distribution
- Nationwide Distribution including TX, VA, OK, and PA
- Lot, serial or model codes
- Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
- 510(k) numbers
- ["K021908"]
- 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