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Terminated

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

FDA Recall Z-0183-06 · Posted 2005-11-23

Recalling FirmTheken Spine LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2005-10-04
Date Terminated2007-02-21
Product Quantity71

Reason for Recall

The torque value of the device may increase over time. The increase could exceed the tolerance specification.

Firm Action

The recalling firm sent consignees a technical bulletin letter, dated 4/4/05.

Root Cause

Other

Distribution Pattern

The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041592CORAL SPINAL SYSTEMTheken Surgical · 2004-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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