Aligned Medical Solutions Spine Pack recall
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Why was Aligned Medical Solutions Spine Pack recalled?
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Lot #s 187143 and 188654; UDI: B098AMS4599C0
- Product
- Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 30 kits
- Distribution
- US: MA OUS: None
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)