Z-0104-2019 Class II Terminated
FDA device recall Z-0104-2019 was initiated by Valeris Medical, LLC on July 16, 2018 and is designated Class II. Reason for recall: The product was mislabeled as containing the incorrect type of suture. The recall status is terminated (terminated August 4, 2020). Affected quantity: 75 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- July 16, 2018
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
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.
Reason for Recall
The product was mislabeled as containing the incorrect type of suture.
Distribution Pattern
Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Code Information
Lot #1982, Exp. 3/22/2019