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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80734

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 16, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Valeris Medical, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-0104-2019
Initiated
July 16, 2018
Classification
Class II
Status
Terminated
Recalling firm
Valeris Medical, LLC
Quantity
75 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.