Recall Z-0183-06 ยท LXH Orthopedic Manual Surgical Instrument
Theken Spine LLC
Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
| Date | Nov 23, 2005 (initiated Oct 4, 2005) |
| Status | Terminated |
| Reason | The torque value of the device may increase over time. The increase could exceed the tolerance specification. |
| Root cause | Other |
| Action | The recalling firm sent consignees a technical bulletin letter, dated 4/4/05. |
| Quantity | 71 |
| Distribution | The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041592 | CORAL SPINAL SYSTEM Theken Surgical, Sep 16, 2004 |