PlainRecalls
FDA Devices Moderate Class II Terminated

IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

Reported: December 16, 2015 Initiated: November 18, 2015 #Z-0397-2016

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.

Details

Recalling Firm
In2Bones, SAS
Units Affected
20 units
Distribution
US Distribution to the state of :TN
Location
Ecully, N/A

Frequently Asked Questions

What product was recalled?
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.. Recalled by In2Bones, SAS. Units affected: 20 units.
Why was this product recalled?
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0397-2016.