Class II — BioPro, Inc.
| Recalling firm | BIOPRO, INC. |
|---|---|
| Registered facility | BIOPRO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Manufacturing flaw in the sterile barrier system |
| Product | Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine |
| Quantity | 2 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland. |
| Initiated | 2019-06-25 |
| Classified | 2019-08-12 |
| Terminated | 2020-05-07 |
| Recall number | Z-2251-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BioPro, Inc. (Z-2251-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83288/
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