—#85683

Product

Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

FDA product code: MQP — Spinal Vertebral Body Replacement Device
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K003836
Affected lot / code info: Catalog number 04.808.002 - all lots.

Why it was recalled

loss of device height

Root cause (FDA determination)

Device Design

Action the firm took

Synthes USA issued an "Urgent: Medical Device Recall" letter to hospital accounts, Synthes personal and sales consultants dated September 23, 2009. Users were asked to take inventory, complete and return a Verification form and return all affected product to the firm. For further information regarding the recall, contact Synthes at 1-800-479-6329 or 1-800-620-7025 extension 5453.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwide Distribution -- Including the United States and Canada.

Timeline

Recall initiated: 2009-09-14
Posted by FDA: 2009-11-09
Terminated: 2015-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85683. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.