Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7
FDA device recall Z-2120-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 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, Austra
- Date initiated
- 2010-04-05
- Date posted
- 2010-08-02
- Date terminated
- 2012-08-28
- Location
- Mahwah, NJ
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