Recall record at a glance
| Official record | Z-0391-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | BioHorizons Implant Systems Inc. |
| Report date | Dec 16, 2015 |
| Recall initiation date | Oct 30, 2015 |
| Quantity | 32 units |
| Location | Hoover, AL, United States |
Official product description
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Why the product was recalled
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Distribution information
Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
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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