FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland
- Recall number
- Z-0475-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 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
- 126 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Hip Fracture Stem # 3.5; Catalog number 6942-0-035; Lot codes: 7566701, 7819401, 7819402, 7819403, 7819405, 7869001, 7869002, 7869003, 7869004, 7869005, 7935701, 7935702, 7935704, 7999901, 7999902, 8152301, 8152302, 8152303, 8242501, 8850401, 8850402, 8850403, 8850404, 9503301, 9844801, 9844802, 9948201, 9948203, 10546201, 10546202, 10673501, 11090201, 11319301, 11319302, 11319303, 11369601, 11605702, 16033902, 16033903, 16165902, 16166001, 16840401, 16840402, 17289401, 17289402, 18448001, 18448002, 19131601, 10131602, 19490903, 19490904, 19834301.
- 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