FDA Medical Device Recalls (openFDA)
Theken Spine LLC: Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
- Recall number
- Z-0183-06
- Recalling firm
- Theken Spine LLC
- Product
- Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
- Status
- Terminated
- Initiated
- 2005-10-04
- Posted
- 2005-11-23
- Terminated
- 2007-02-21
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K041592"]
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3002498892
- Firm city
- Akron
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28