Recall record at a glance
| Official record | Z-0738-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | NuVasive Inc. |
| Report date | Dec 28, 2022 |
| Recall initiation date | Nov 10, 2022 |
| Quantity | 2,031 devices |
| Location | San Diego, CA, United States |
Official product description
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Why the product was recalled
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
Distribution information
Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA, HI, AL, NY, WI, AR, ID, VA, PA, SC, MD, PA, AZ, RI, IN, ME, NJ, MI, TN, MN, OR, OK, WY, and Puerto Rico. The countries of Australia, Belgium, Brazil, Colombia, Germany, Italy, Spain, and United Kingdom.
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: Letter.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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