—#122390

Product

Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V). The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

FDA product code: KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061353
Affected lot / code info: Lots: P060509, P061255, P070617, P080422, P090046

Why it was recalled

Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer Spine sent a Medical Device Correction letter dated October 9, 2013 via FedEx A Medical Device Correction letter, dated October 09, 2013 via FedEx to distributors, Hospitals and Surgeons who have received and/or used the device. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of its contents. Only sterilize the Ratchet Handles external to the instrument tray. Customers were to be notified when replacement trays were available. Customer with questions were instructed to call the Zimmer Customer Call Center at 866-774-6368. UPDATE: July 17, 2014 Zimmer issued another letter to consignees to inform them of a redesigned tray is available and will replace the current tray. A Zimmer representative will conduct the swap-out of the current Rev A tray for the new Rev B design tray. A Return Confirmation Form is asked to be emailed back to CorporateQuality.Postmarket@zimmer.com. For assistance or questions, contact Zimmer Spine Customer Service at 866-774-6368.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Nationwide and OUS countries include: Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, Switzerland, and the UK.

Timeline

Recall initiated: 2013-10-09
Posted by FDA: 2013-11-18
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122390. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.