FDAClass IIOctober 24, 2018

Valeris Medical Apollo Medial Suture Anchor recall: Labeling Error

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…

Why was Valeris Medical Apollo Medial Suture Anchor recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #1982, Exp. 3/22/2019

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…
Recalling firm
Valeris Medical, LLC
Quantity
75 units
Distribution
Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Recall date
October 24, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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