FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Howmedica Hip Fracture Stem System No. 4 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-040 Made in Ireland
- Recall number
- Z-0476-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Howmedica Hip Fracture Stem System No. 4 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-040 Made in Ireland
- Status
- Terminated
- Initiated
- 2006-11-28
- Posted
- 2007-01-13
- Terminated
- 2007-05-08
- Reason
- Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
- Root cause
- Other
- Action
- Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
- Quantity
- 67 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Hip Fracture Stem # 4; Catalog number 6942-0-040; Lot codes: 7567401, 7799201, 7868901, 7868902, 7868903, 7936001, 7936002, 8243001, 8243002, 9401001, 9948301, 9948302, 9948304, 14342101, 17596001, 17596002, 17810901, 17969201, 18062501, 18062502, 18062503, 8243003R, MPRTA.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KWL
- 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