FDA recall Z-0104-2019

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 for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-07-16

Report date

2018-10-24

Termination date

2020-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2019