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Terminated

Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.

FDA Recall Z-0932-2013 · Posted 2013-03-10

Recalling FirmSpine Smith Partners LP
Recall StatusTerminated
Product CodeMAX
Date Initiated2012-08-24
Date Terminated2013-05-17
Product Quantity3 units

Reason for Recall

Implants were incorrectly laser marked as 23mm instead of 28mm.

Firm Action

Spine Smith sent a Field Action Notice dated August 24, 2012 to its affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 512-637-2097 for questions concerning this notice.

Root Cause

Labeling mix-ups

Distribution Pattern

Distributed in Texas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101085SPINESMITH CYNCH SPINAL SYSTEMSpine Smith Partners L.P. · 2010-07-01

Official Source

View FDA Recall →

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

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