Torque Limiting Handle, model # 10-40-0122, a component of… recallZ-0183-06 · Theken Spine LLC · initiated Oct 4, 2005
Terminated All recalls posted in November 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Theken Spine LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The torque value of the device may increase over time. The increase could exceed the tolerance specification.
FDA root cause category: Other
What the company is doing
The recalling firm sent consignees a technical bulletin letter, dated 4/4/05.
Recall details
- Recall number
- Z-0183-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 4, 2005
- Posted by the FDA
- Nov 23, 2005
- Recalling firm
- Theken Spine LLC
- Quantity
- 71
- Product code
- LXH
- FDA submissions
- K041592
- Distribution
- The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.
Product description
Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under K041592 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Coral 10-17-0001Seaspine Orthopedics Corporation · Orthosis, spondylolisthesis spinal fixation3 reports
- Coral 10-18-0045Seaspine Orthopedics Corporation · Orthosis, spondylolisthesis spinal fixation1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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