Medical Device Recalls

510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA

New Search Back to Search Results   Class 1 Recall TI Synex (TM) II Central Body 37mm - 52mm Date Posted November 09, 2009 Recall Number Z-0113-2010 Product Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. 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. Code Information Catalog number 04.808.006 - all lots. Recalling Firm/ Manufacturer Synthes USA (HQ), Inc. 1302 Wrights Ln E West Chester, Pennsylvania 19380-3417 Consumer Instructions Contact the recalling firm for information For Additional Information Contact Lynne Lewis 800-620-7025 Ext. 5433 Reason for Recall loss of device height Action 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. Quantity in Commerce 221 units Distribution Worldwide Distribution -- Including the United States and Canada.