Oblique Posterior Atraumatic Lumbar recall
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve…
Why was Oblique Posterior Atraumatic Lumbar recalled?
The label on the outer packaging does not match the product inside and intended use of the device.
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?
Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
- Product
- Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 6 units
- Distribution
- Distributed in the US: OH and ND
- Recall date
- April 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)