FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Howmedica Hip Fracture Stem System No. 2 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-020 Made in Ireland
- Recall number
- Z-0473-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Howmedica Hip Fracture Stem System No. 2 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-020 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
- 731 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Hip Fracture Stem # 2: Catalog Number 6942-0-020; Lot Codes: 7237501, 7237502, 7237503, 7237505, 7600201, 7600202, 7662301, 7662302, 7662303, 7662304, 7692401, 7692402, 7692403, 7692406, 7805601, 7805602, 7805603, 7805604, 7934901, 7934902, 7944903, 7934904, 7999101, 7999102, 7999103, 7999104, 8152001, 8152002, 8152003, 8152004, 8152005, 8152006, 8152101, 8152102, 8152103, 8152104, 8241701, 8241702, 8241703, 8241704, 8241705, 8241706, 8345701, 8345702, 8345703, 8345704, 8478101, 8478102, 8478103, 8478104, 8569601, 8569602, 8632901, 8632902, 8633001, 8633101, 8633201, 8791103, 8791104, 8971301, 8993501, 8994801, 8995001, 8995601, 8995701, 9004401, 9004402, 9243601, 9243602, 9243603, 9400701, 9400702, 9400703, 9400704, 9400705, 9400706, 9475901, 9714101, 9714102, 9714104, 9911701, 9911702, 9911703, 9911705, 9911706, 9967201, 9967202, 9967203, 10353602, 10362901, 10420901, 10421001, 10585002, 10585003, 10585004, 10585005, 10585006, 10673301, 10673302, 10673303, 11064601, 11064602, 11064603, 11089903, 11089904, 11369301, 11369302, 11369303, 11436901, 11436902, 11605301, 11604302, 11791901, 11791902, 11791903, 11920901, 11920902, 11920903, 12084501,12084502, 12084503, 12084505, 12406801, 12406802, 12406803, 12406901, 12947501, 12947502, 12947503, 12947504, 13184201, 13184202, 13184203, 13184204, 13184301, 13412201, 13412202, 13412203, 13782102, 13782104, 13793501, 13973502, 13984701, 13984702, 13984703, 14108402, 14196701, 14196702, 14274601, 14368101, 14368102, 14368103, 15485101, 15485102, 15485103, 15485104, 15485105, 15668701, 15668702, 15953601, 15953602, 15953603, 15953604, 15953605, 15953606, 16059801, 16059802, 16059803, 16165601, 16203701, 16203702, 16499401, 16499402, 16499403, 16499404, 16937901, 16937902, 16937904, 17220101, 17220102, 17220103, 17220104, 17307801, 17307802, 17307804, 17658001, 17658002, 17658003, 17745201, 17745202, 17745203, 17969401, 17969402, 18320601, 18320602, 18448602, 18594101, 18594102, 18594601, 19246901, 19247001, 19247101, 19329001, 19329002, 19532501, 19532504, 19577101, 19577102,19826201, 19826203, 15953604R, 19329001R, 7805601R.
- 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