SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
FDA Recall Z-2583-2010 · Posted None
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Recalling FirmSynthes USA (HQ), Inc.
Recall StatusTerminated
Product CodeMQP
Date Initiated2010-07-23
Date Terminated2014-12-18
Reason for Recall
A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.
Firm Action
Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: [email protected].
If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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