—#93275

Product

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 product code: MQP — Spinal Vertebral Body Replacement Device
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K053508
Affected lot / code info: Catolog Number: 03.802.039 - all lot numbers

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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: FieldAction@Synthes.com. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.

Timeline

Recall initiated: 2010-07-23
Terminated: 2014-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93275. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.