FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: S2 System, Locking Screw Partially Threaded
- Recall number
- Z-0166-06
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- S2 System, Locking Screw Partially Threaded
- Status
- Terminated
- Initiated
- 2005-10-04
- Posted
- 2005-11-18
- Terminated
- 2006-05-04
- Reason
- Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
- Root cause
- Other
- Action
- The product recall will extend to all branches.agencies and hospitals that have received the product.
- Quantity
- 171 units
- Distribution
- nationwide
- Lot, serial or model codes
- Catalog No. 1791-5065S to 1791-5120S
- 510(k) numbers
- ["K021026"]
- PMA numbers
- not on file
- Product code
- HWC
- 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