FDA Medical Device Recalls (openFDA)
Stelkast Co: Proven Porous CR Femur. Implantable orthopedic device
- Recall number
- Z-0496-05
- Recalling firm
- Stelkast Co
- Product
- Proven Porous CR Femur. Implantable orthopedic device
- Status
- Terminated
- Initiated
- 2004-09-24
- Posted
- 2005-02-03
- Terminated
- 2005-02-07
- Reason
- Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch
- Root cause
- Other
- Action
- The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.
- Quantity
- 105 units
- Distribution
- The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA.
- Lot, serial or model codes
- Catalog number SC2113-2 Lot number 3763-012501, Catalog number SC2113-3 Lot number 3764-012501, Catalog number SC2113-4 Lot number 3765-012501, Catalog number SC2113-1 Lot number 3762-012501, Catalog number SC2113-6 Lot number 3767-012501, Catalog number SC2113-5 Lot number 3766-012501, Catalog number SC2114-4 Lot number 3771-012501, Catalog number SC2114-3 Lot number 3770-012501, Catalog number SC2114-1 Lot number 3768-012501, Catalog number SC2114-2 Lot number 3769-012501, Catalog number SC2114-6 Lot number 3773-012501, and Catalog number SC2114-5 Lot number 3772-012501.
- 510(k) numbers
- ["K002281"]
- 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