Howmedica Osteonics Corp, Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 765
FDA device recall Z-2118-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part.
- Action taken
- Stryker Urgent Product Recall letters dated April 8, 2010, were sent by Federal Express to Stryker Branches/agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 676 in US, 1305 internationally.
- Distribution
- Worldwide distribution.
- Date initiated
- 2010-04-05
- Date posted
- 2010-08-02
- Date terminated
- 2012-08-28
- Location
- Mahwah, NJ
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