Recall Z-0397-2016— In2Bones, SAS

Name: FDA recall Z-0397-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-18

Class II · Terminated

Class II FDA medical device recall by In2Bones, SAS, initiated 2015-11-18, terminated 2016-08-19. It names one FDA 510(k) clearance: K131920. Product: IBS - Osteosynthesis screws for bone fixation Model S25 ST014.. Reason: One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head..

Recalling firm: In2Bones, SAS
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Terminated: 2016-08-19
Firm location: Ecully, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K131920 — STABILIZATION SCREWIn2bones Sas·cleared 2014-05-01

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

IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

Reason for recall

One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

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