FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
- Recall number
- Z-0391-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
- Status
- Terminated
- Initiated
- 2009-09-04
- Posted
- 2009-11-23
- Terminated
- 2013-06-26
- Reason
- Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
- Root cause
- Process control
- Action
- Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
- Quantity
- 10 units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Catalog number 6260-9-132; Lot Code 28759003
- 510(k) numbers
- ["K010757","K022077","K061434","K993601"]
- PMA numbers
- not on file
- Product code
- JDG
- 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