FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
- Recall number
- Z-2080-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
- Status
- Terminated
- Initiated
- 2005-08-17
- Posted
- 2008-09-16
- Terminated
- 2008-09-24
- Reason
- Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
- Root cause
- Device Design
- Action
- Letters were sent to Stryker branches and hospitals on August 17, 2005. If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025.
- Quantity
- 105 units
- Distribution
- The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide
- Lot, serial or model codes
- Catalog Number: 4940-9-810: Lot Codes: H11883, H13813, H17174, H18891, K01047, K03042, K05896.
- 510(k) numbers
- ["K971755"]
- PMA numbers
- not on file
- Product code
- JEC
- 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