Model Catalog: 9735500 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 9734716 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 9734715 (Lot serial: >10 lot numbers contact mfg)
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Medtronic Spinous Process ClampsSpine Referencing InstrumentationModel/Catalogue Numbers9734715 Spinous Process Clamp, Tall9734716 Spinous Process Clamp, Short9734723 Double Spinous Process Clamp, Tall9734724 Double Spinous Process Clamp, Short 9734715K Spinous Process Clamp, Tall9734716K Spinous Process Clamp, Short9734723K Double Spinous Process Clamp, Tall9734724K Double Spinous Process Clamp, Short9735500 Set (contains 9734715 & 9734716)ARTG Number: 125074