Recall Z-1581-2010 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 11; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
| Date | May 10, 2010 (initiated Dec 3, 2009) |
| Status | Terminated |
| Reason | The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block. |
| Root cause | Device Design |
| Action | Urgent Product Recall Letters were sent on December 3, 2009 via Federal Express to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. Foreign accounts were notitied on December 7, 2009. Questions or comments should be addressed to Colleen O'Meara at 201-972-2100. |
| Quantity | 9833 Scorpio Cutting Blocks, total |
| Distribution | Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.