Zimmer Spine, Inc. Recalls
Showing 1-5 of 5 recalls
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.
Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to corporatequality.postmarket@zimmerbiomet.com. Questions or concerns can be directed to Customer Service at 1-866-774-6368
Universal Clamp System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001).
Consignees were sent on 2-12-2016 a Zimmer Biomet "Urgent Medical Device Correction Notice" letter dated February 12, 2016. The letter was either addressed to Hospital Representative or to Distributors, Sales Representatives, and Distribution Operations Managers. The letters described the problem and the product involved in the recall. Advised consignees to immediately utilize the updated and attached Instructions For Use. Requested consignees to complete the "Acknowledgement of Field Notification" form. For questions contact Customer Service at 1-866-774-6368 or e-mail corporatequality.postmarket@zimmerbiomet.com.
Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. Th
Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.
Distributors were notified via email with an Urgent Product Recall letter beginning 10/12/2006. Distributors are to return their own inventory and any hospital consignment inventory by October 20, 2006. A Certification Form is also to be faxed back to Zimmer Spine.
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.
The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.
Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
The recalled bone taps could break inside the vertebral body during the tapping process.
Recall letters, dated May 25, 2004, request that the consignees locate and return the recalled devices.