Opal, Intervertebral Cage, 10x32mm, h 11mm recall: Sterility Concern
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Why was Opal, Intervertebral Cage, 10x32mm, h 11mm recalled?
Products not sterilized, sterility cannot be confirmed
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?
UDI: 07611819318489 Lot Number: 427P153
- Product
- Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 30 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
- Recall date
- March 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)