FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Howmedica Hip Fracture Stem System, Product Number: 6942-0-10, No. 1 Femoral Component, Fenestrated Sterile Made in Ireland
- Recall number
- Z-0472-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Howmedica Hip Fracture Stem System, Product Number: 6942-0-10, No. 1 Femoral Component, Fenestrated Sterile 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
- 193 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Hip Fracture Stem # 1; Catalog Number 6942-0-010; Lot codes: 6499601, 6660201, 6660202, 6660203, 6660204, 6660205, 7237401, 7237402, 7237403, 7237404, 7237405, 7934101, 7934102, 7934103, 7934104, 7934105, 8345801, 8345802, 8345803, 8345804, 9714001, 9911901, 9911902, 10420701, 10420702, 10756001, 11319201, 11369101, 11369102, 11369103, 11605201, 11605202, 13093201, 13093301, 13093302,13093401, 13093501, 13562501, 13562502, 13782001, 15550502, 16060001, 16060002, 16840301, 17289301, 17289302, 18448101, 18448102, 18448103, 18593901, 14413201R, P4FEA.
- 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