Z-0104-2019Class II

Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1)...

Name: Z-0104-2019 Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1)...
Creator: Valeris Medical, LLC
Published: 2018-07-16
License: https://open.fda.gov/license/

Valeris Medical / initiated 2018-07-16 / Terminated / root cause: manufacturing process

FDA source

Valeris Medical, LLC began a recall of 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... on 2018-07-16. FDA classified it as Class II and gives the reason as "The product was mislabeled as containing the incorrect type of suture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0104-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-16
Posted: 2018-10-12
Terminated: 2020-08-04
Recalling firm: Valeris Medical
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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: The product was mislabeled as containing the incorrect type of suture.
Root cause tag: manufacturing process
FDA 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 in commerce: 75 units
Distribution: Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Product codes and lots: Lot #1982, Exp. 3/22/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0104-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0104-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-12

Product code MBI

K133036Class IIApollo Suture Anchor System and Titan ScrewsAmendia, Inc. / cleared 2014-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)