Valeris Medical Apollo Medial Suture Anchor recalled over labeling errors

Recall date

July 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Valeris Medical, LLC recalls Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw,…

Recall number

Z-0104-2019

FDA classification

Class II

Brand / firm

Valeris Medical, LLC

Sold / distributed

Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.