Recall record at a glance
| Official record | Z-2527-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | TeDan Surgical Innovations LLC |
| Report date | Jul 15, 2020 |
| Recall initiation date | May 15, 2020 |
| Quantity | 1965 screws (packaged into 393 boxes) - [5 screw per box] |
| Location | Sugar Land, TX, United States |
Official product description
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Why the product was recalled
Lack of pouch seal. Product is labelled as sterile.
Distribution information
Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., 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: E-Mail.
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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