FDA Medical Device Recalls (openFDA)
Valeris Medical, LLC: 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 number
- Z-0104-2019
- Recalling firm
- Valeris Medical, LLC
- 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.
- Status
- Terminated
- Initiated
- 2018-07-16
- Posted
- not on file
- Terminated
- 2020-08-04
- Reason
- The product was mislabeled as containing the incorrect type of suture.
- Root cause
- Process control
- 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.
- Quantity
- 75 units
- Distribution
- Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
- Lot, serial or model codes
- Lot #1982, Exp. 3/22/2019
- 510(k) numbers
- ["K133036"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3010841252
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28