Recall Z-0398-2020— Orthofix Srl

Name: FDA recall Z-0398-2020
Creator: U.S. Food and Drug Administration
Published: 2018-09-27

Class II · Terminated

Class II FDA medical device recall by Orthofix Srl, initiated 2018-09-27, terminated 2022-02-01. It names one FDA 510(k) clearance: K113770. Product: ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895. Reason: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance..

Recalling firm: Orthofix Srl
Classification: Class II
Status: Terminated
Initiated: 2018-09-27
Terminated: 2022-02-01
Firm location: Veronaverona, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K113770 — ORTHOFIX GALAXY FIXATION SYSTEMOrthofix Srl·cleared 2012-09-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895

Reason for recall

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.