Device 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.
Z-0104-2019
Product summary
- Event
- Event 80734
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-0104-2019
Official wording
Reason: The product was mislabeled as containing the incorrect type of suture.
Code information: Lot #1982, Exp. 3/22/2019
Distribution pattern: Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Derived failure modes
-
Labeling or packaging
mislabeled