FDA Recall
Terminated
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.
Recall: Z-0104-2019
·
Initiated July 16, 2018
Recall
- Recall Number
- Z-0104-2019
- Event Number
- 80734
- Firm
- Valeris Medical, LLC
- FEI Number
- 3010841252
- Product Code
- MBI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 16, 2018
- Terminated
- August 4, 2020
- Address
- 200 Cobb Pkwy N, Bldg 200 Ste 210, Marietta, GA, 30062-3500
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
The product was mislabeled as containing the incorrect type of suture.
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.
Distribution
Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Quantity
75 units