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.
FDA Recall Z-0104-2019 · Posted None
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Recalling FirmValeris Medical, LLC
Recall StatusTerminated
Product CodeMBI
Date Initiated2018-07-16
Date Terminated2020-08-04
Product Quantity75 units
Reason for Recall
The product was mislabeled as containing the incorrect type of suture.
Firm Action
The recalling firm issued a letter dated 7/13/2018 via email on 7/16/2018 to their consignees to inform them the product is mislabeled and contains blue and green sutures rather than blue and white sutures as is indicated on the label.
Root Cause
Process control
Distribution Pattern
Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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