Marietta, GA, United States
Valeris Medical, LLC recalls
2 recalls recorded since 2018, most recently on 16 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 July 2018
- Terminated
- 4 August 2020
- Reason
- The product was mislabeled as containing the incorrect type of suture.
- Distribution
- Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0104-2019
- 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 fir
Terminated Class II Medical devices
- Recall started
- 22 January 2018
- Terminated
- 9 April 2021
- Reason
- The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.
- Distribution
- US Nationwide Distribution in the states of California and Oklahoma.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2430-2018
- Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repa
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.