Valeris Medical Recalls Apollo XT Suture Anchors Due to Material Mislabeling
Valeris Medical is recalling 113 Apollo XT Suture Anchors because the labels incorrectly identified the material as titanium instead of PEEK.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding material composition (titanium vs. PEEK) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Valeris Medical, LLC is recalling 113 units of the Apollo XT Suture Anchor, Model No. XT-5515, Lots 2358, 2362, and 2363. The recall was initiated because the product labels incorrectly stated that the anchor screw material was titanium, whereas the specific part number is actually made of PEEK (polyether ether ketone).
The affected devices were distributed in the United States, specifically in the states of California and Oklahoma. These suture anchors are intended for various orthopedic procedures, including rotator cuff repair, Bankart repair, and ligament reconstruction in the shoulder, foot/ankle, knee, elbow, and hip.
Healthcare providers and patients should stop using the affected lots and contact Valeris Medical for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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 Repair - Deltoid Repair - Capisular Shift or Capsulolabral Recon
- Manufacturer
- Valeris Medical, LLC
- Hazard
- Affected units
- 113
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model No. XT-5515
- Lot No. 2358
- 2362
- 2363
Distribution
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