Recall Z-0325-2018— Amendia, Inc

Name: FDA recall Z-0325-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-07

Class II · Terminated

Class II FDA medical device recall by Amendia, Inc, initiated 2017-07-07, terminated 2019-10-15. It names one FDA 510(k) clearance: K153152. Product: Mac Pin Non-Cannulated Screw, 6.5 x 60mm. Reason: Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length..

Recalling firm: Amendia, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-07-07
Terminated: 2019-10-15
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K153152 — Syzygy Stabilization SystemAmendia, Inc.·cleared 2016-04-27

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

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Reason for recall

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

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