FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003.
- Recall number
- Z-2120-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003.
- Status
- Terminated
- Initiated
- 2010-04-05
- Posted
- 2010-08-02
- Terminated
- 2012-08-28
- Reason
- One of the two posts on the Anterior Resection Guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld.
- Root cause
- Device Design
- Action
- Stryker Urgent Product Recall letters dated April 5, 2010, were sent out via Federal Express to Stryker branches/agencies, Hospital Risk Management, hospital Chief of Orthopedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified. Questions and/or concerns should be directed to Rich Wolyn at 201-972-2100.
- Quantity
- 682 units in US, 1292 units internationally.
- Distribution
- Worldwide distribution: USA, Ireland, Germany, Sweden, The Netherlands, France, Italy, Switzerland, South Africa, United Kingdom, Japan, Argentina, Mexico, Miramar (city), China, Taiwan, India, Australia, Korea, New Zealand, Malaysia, Singapore, and Canada.
- Lot, serial or model codes
- Catalog Number 7650-5003; all lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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