FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Howmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-030 Made in Ireland
- Recall number
- Z-0474-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Howmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-030 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
- 540 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Hip Fracture Stem # 3; Catalog number 6942-0-030, Lot codes: 7238602, 7238603, 7238604, 7353002, 7353003, 7600501, 7600502, 7692501, 7692503, 7692504, 7692505, 7292506, 7935101, 7935102, 7935103, 7999701, 7999702, 7999703, 7999801, 7999803, 8152201, 8152203, 8152204, 8152205, 8152206, 8152207, 8152208, 8241801, 8241802, 8242101, 8252102, 8242103, 8345503, 8345504, 8531601, 8531901, 8532001, 8532301, 8532401, 8532501, 8532601, 8643301, 8643302, 8643303, 8643304, 8643305, 8850801, 8850802, 8850901, 8850902, 8850903, 9011101, 9044301, 9044302, 9044303, 9044304, 9090101, 9124401, 9400801, 9400802, 9400803, 9503202, 9574801, 9911802, 9911803, 9948101, 9948102, 10164601, 10164602, 10212501, 10317501, 10353702, 10353703, 10917801, 10917802, 10917803, 10917804, 10917806, 11064501, 11064503, 11092701, 11092702, 11092703, 11092704, 11092705, 11369401, 11369402, 11605501, 11607801, 12407001, 12407003, 12407005, 12407006, 12870602, 12870603, 12870604, 12947201, 12947202, 12947203, 13294601, 13294602, 13294603, 13294604, 13294605, 13294606, 13412101, 13412102, 13412103, 13412104, 13782202, 13782203, 13782204, 13782205, 14377903, 14412801, 14412804, 14412805, 14682701, 14682702, 14738901, 15236201, 15550301, 15550302, 15550303, 16059701, 16059703, 16059704, 16059705, 16059706, 16165503, 16499502, 16750801, 16937801, 16937802, 16937803, 16937804, 16937805, 16937806, 17540401 17540402, 17657902, 17657903, 17745101, 17842801, 17842802, 17842803, 18062101, 18062202, 18131401, 18131402, 18131403, 18448701, 18448702, 18594201, 18594202, 18594203, 18946901, 18946902, 19428801, 19673002, 19673003, 19673004, 19726201, 20304601, 20304602, 20304604, 20304607, 7023401R.
- 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