CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Apollo Medial Suture Anchor recalled by Valeris Medical
Valeris Medical is recalling Apollo Medial Suture Anchor, distributed in Florida, Ohio, Oklahoma, Texas. The recall was initiated on 16 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0104-2019
- FDA event ID
- 80734
- Recalling firm
- Valeris Medical, Marietta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2018
- FDA classified
- 12 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 16 Jul 2018 | Recall initiated by company | |
| 12 Oct 2018 | Classified by FDA | +88 days |
| 24 Oct 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product was mislabeled as containing the incorrect type of suture.
Product as listed by the FDA
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.
Where it was distributed
Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
Questions about this recall
Why was it recalled?
The product was mislabeled as containing the incorrect type of suture.
Which lots are affected?
Lot #1982, Exp. 3/22/2019
Where was it sold?
Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Valeris Medical
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|---|---|---|---|---|---|
| Device | CLASS II | Apollo XT Suture Anchor recalled by Valeris Medical | Valeris Medical | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |