Arthrex Deltoid Ligament Reconstruction Implant System. recall: Sterility Concern
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over…
Why was Arthrex Deltoid Ligament Reconstruction Implant System. recalled?
Potential for a component contained in the Implant System to be non-sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
- Product
- Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over…
- Recalling firm
- Arthrex, Inc.
- Quantity
- 117 devices
- Distribution
- Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.
- Recall date
- April 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)