Valeris Medical Apollo Medial Suture Anchor Recalled for Mislabeling
Valeris Medical is recalling 75 units of Apollo Medial Suture Anchors because the product was mislabeled as containing the incorrect type of suture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding the suture type, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Valeris Medical, LLC is recalling 75 units of the Apollo Medial Suture Anchor, Catalog Number MSA-4515. The product is a sterile, prescription medical device consisting of a PEEK Screw and ForceBraid sutures. The recall is due to a labeling error where the product was mislabeled as containing the incorrect type of suture.
The affected units are from Lot #1982, with an expiration date of 3/22/2019. Distribution was made to Florida, Ohio, Oklahoma, and Texas, as well as to the United Kingdom and New Zealand. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected suture anchors and contact Valeris Medical for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Valeris Medical, LLC
- Hazard
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #1982
- Exp. 3/22/2019
Distribution
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