Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
FDA device recall Z-0183-06 · posted 2005-11-23 · Terminated
Recall details
- Recalling firm
- Theken Spine LLC
- Reason for recall
- The torque value of the device may increase over time. The increase could exceed the tolerance specification.
- Action taken
- The recalling firm sent consignees a technical bulletin letter, dated 4/4/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 71
- Distribution
- The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.
- Date initiated
- 2005-10-04
- Date posted
- 2005-11-23
- Date terminated
- 2007-02-21
- Location
- Akron, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORAL SPINAL SYSTEM (K041592) | Theken Surgical | 2004-09-16 |