Recall record at a glance
| Official record | Z-1845-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Biomet, Inc. |
| Report date | Jun 26, 2019 |
| Recall initiation date | Apr 1, 2019 |
| Quantity | 313 units |
| Location | Warsaw, IN, United States |
Official product description
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The 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
Why the product 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
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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