Recall Z-0357-2014 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Zimmer, Inc.
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 an
| Date | Nov 18, 2013 (initiated Oct 9, 2013) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 quest |
| Quantity | 94 Tray sets |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061353 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM Zimmer Spine, Inc., Aug 30, 2006 |