ORTHOFIX — Class II medical device recall Z-1363-2018
Terminated recall by Orthofix, Inc, reported 2018-04-18. Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected
| Recall number | Z-1363-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2018-02-23 |
| Classified | 2018-04-11 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-06-18 |
| Quantity | 397 units |
| UPC / GTIN / UDI-DI | 18257200125371 |
| Lot numbers | O02, O03, O04 |
| Model numbers | 79-2003 |
Product
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Reason for recall
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
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-1363-2018. 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.