Recall Z-0919-2013 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
| Date | Mar 8, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. |
| Root cause | Process control |
| Action | Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue. |
| Quantity | 48 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.