Recall Z-0932-2013— Spine Smith Partners LP

Name: FDA recall Z-0932-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-24

Class II · Terminated

Class II FDA medical device recall by Spine Smith Partners LP, initiated 2012-08-24, terminated 2013-05-17. It names one FDA 510(k) clearance: K101085. Product: Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.. Reason: Implants were incorrectly laser marked as 23mm instead of 28mm..

Recalling firm: Spine Smith Partners LP
Classification: Class II
Status: Terminated
Initiated: 2012-08-24
Terminated: 2013-05-17
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K101085 — SPINESMITH CYNCH SPINAL SYSTEMSpine Smith Partners L.P.·cleared 2010-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.