Recall Z-0738-06 ยท LXH Orthopedic Manual Surgical Instrument
Medtronic Sofamor Danek Instrument Manufacturing
METRx II Tube, 18mm x 8cm stainless steel tubular retractor, Part No. 9569685
| Date | Apr 12, 2006 (initiated Jan 25, 2006) |
| Status | Terminated |
| Reason | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. |
| Root cause | Other |
| Action | The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product. |
| Quantity | 4 |
| Distribution | IL, IN, MI, CA, Japan, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.