FDA-Device2018-10-24Class II
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.
Valeris Medical, LLC
Hazard
The product was mislabeled as containing the incorrect type of suture.
Sold states
Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Affected count
75 units
Manufactured in
200 Cobb Pkwy N Bldg 200 Ste 210, N/A, Marietta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2019Don't want to check this manually?
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