FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads.
- Recall number
- Z-0556-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads.
- Status
- Terminated
- Initiated
- 2009-01-14
- Posted
- 2009-12-22
- Terminated
- 2012-07-18
- Reason
- Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
- Root cause
- Device Design
- Action
- Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.
- Quantity
- 786 total stems
- Distribution
- Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.
- Lot, serial or model codes
- Catalog numbers: J6051-0425, J0651-0525, J6051-0625. All lot codes with an expiry prior to Aug. 2013.
- 510(k) numbers
- ["K020615"]
- PMA numbers
- not on file
- Product code
- MEH
- 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