Recall Z-2118-2010 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp, Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005.
| Date | Aug 2, 2010 (initiated Apr 5, 2010) |
| Status | Terminated |
| Reason | There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 676 in US, 1305 internationally. |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.