FDA Medical Device Recalls (openFDA)
Stelkast Co: Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
- Recall number
- Z-1066-2013
- Recalling firm
- Stelkast Co
- Product
- Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
- Status
- Terminated
- Initiated
- 2013-01-24
- Posted
- 2013-04-07
- Terminated
- 2014-10-08
- Reason
- Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
- Root cause
- Device Design
- Action
- The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.
- Quantity
- 254
- Distribution
- Nationwide Distribution including the states of NV, OK and PA.
- Lot, serial or model codes
- Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.
- 510(k) numbers
- ["K122773"]
- PMA numbers
- not on file
- Product code
- OQG
- 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