Recall Z-0521-2007 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Leibinger USA
Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.
| Date | Feb 27, 2007 (initiated Dec 22, 2006) |
| Status | Terminated |
| Reason | Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated 12/22/06 which instructed them to quarantine the product and to contact the firm for further instructions. |
| Quantity | 26 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.