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Terminated

ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

FDA Recall Z-1363-2018 · Posted None

Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeNKG
Date Initiated2018-02-23
Date Terminated2019-06-18
Product Quantity397 units

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.

Firm Action

The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172194Connector SystemOrthofix, Inc. · 2017-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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