Reported Jun 26, 2019 · Terminated
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number:…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement
- Item Number0024-LDR TEDAN
- SURGICAL INNOVATIONS LLC DISTRIBUTED BYLDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN
- TX 78750 Product UsageThe device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery
- Lot codes and dates
- Lot Number2017102450
- Amount recalled
- 313 units
Where it was sold
- Nationwide
Why it was recalled
Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw
This product could cause temporary or reversible health problems — stop using it.
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