Accolade and Restoration hip product recall: Sterility Concern
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Why was Accolade and Restoration hip product recalled?
Inner and outer sterile barriers not fully sealed.
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: 56211103, 56211401, 56211704, 57284004
- Product
- Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 255
- Distribution
- Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)