RAPIDSORB IPS Battery Pack recall: Sterility Concern
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton…
Why was RAPIDSORB IPS Battery Pack 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: 10887587057262 Lot Number: 499P371
- Product
- RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 10 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)