Go-EZ Screw 6 — Class II medical device recall Z-2250-2019
Terminated recall by BioPro, Inc., reported 2019-08-21, distributed nationwide. Manufacturing flaw in the sterile barrier system
| Recall number | Z-2250-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioPro, Inc., Port Huron, MI, United States |
| Recall initiated | 2019-06-25 |
| Classified | 2019-08-12 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2020-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | EC, GB |
| Quantity | 3 units |
| Reason classes | sterility |
| Lot numbers | 123107 |
| Model numbers | 19653 |
Product
Go-EZ Screw 6.5x34, Item Number 19653 - 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
Reason for recall
Manufacturing flaw in the sterile barrier system
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2250-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.