Z-0183-06

Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System)

Name: Z-0183-06 Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System)
Creator: Theken Spine LLC
Published: 2005-10-04
License: https://open.fda.gov/license/

Theken Companies LLC / initiated 2005-10-04 / Terminated

FDA source

Theken Spine LLC began a recall of Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System) on 2005-10-04. The reason FDA records is "The torque value of the device may increase over time. The increase could exceed the tolerance specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0183-06
Status: Terminated
Initiated: 2005-10-04
Posted: 2005-11-23
Terminated: 2007-02-21
Recalling firm: Theken Companies LLC
Product: Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The torque value of the device may increase over time. The increase could exceed the tolerance specification.
FDA root cause: Other
Action: The recalling firm sent consignees a technical bulletin letter, dated 4/4/05.
Quantity in commerce: 71
Distribution: The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.
Product codes and lots: The Torque handles contain serial #1 through serial #76 and are part number 10-40-0122 contained in the Coral Lumbar System, Lot W1902 and W1558.

Product code LXH

K041592Class IICoral Spinal SystemTheken Surgical / cleared 2004-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)