Theken Spine LLC Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
Brand
Theken Spine LLC
Lot Codes / Batch Numbers
Lot W1902 and W1558.
Products Sold
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.
Theken Spine LLC is recalling Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw Sy due to The torque value of the device may increase over time. The increase could exceed the tolerance specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The torque value of the device may increase over time. The increase could exceed the tolerance specification.
Recommended Action
Per FDA guidance
The recalling firm sent consignees a technical bulletin letter, dated 4/4/05.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV
Page updated: Jan 10, 2026