Recall Z-0104-2019— Valeris Medical, LLC

Name: FDA recall Z-0104-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-16

Class II · Terminated

Class II FDA medical device recall by Valeris Medical, LLC, initiated 2018-07-16, terminated 2020-08-04. It names one FDA 510(k) clearance: K133036. Product: Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.. Reason: The product was mislabeled as containing the incorrect type of suture..

Recalling firm: Valeris Medical, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-07-16
Terminated: 2020-08-04
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K133036 — APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWSAmendia, Inc.·cleared 2014-03-06

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

Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.

Reason for recall

The product was mislabeled as containing the incorrect type of suture.

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