FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics: Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
- Recall number
- Z-0719-04
- Recalling firm
- Stryker Howmedica Osteonics
- Product
- Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
- Status
- Terminated
- Initiated
- 2004-02-10
- Posted
- 2004-07-20
- Terminated
- 2004-06-09
- Reason
- The Cylindrical Distal Extensions were incorrectly coded and packaged.
- Root cause
- Other
- Action
- Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.
- Quantity
- 20
- Distribution
- The 9 units were sent out to 2 US branch/agents and one international distributor.
- Lot, serial or model codes
- Lots: 96910501; 96949401; 96940901; 96950901.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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