FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- Recall number
- Z-0940-2018
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- Status
- Terminated
- Initiated
- 2017-07-21
- Posted
- not on file
- Terminated
- 2020-03-12
- Reason
- Inner and outer sterile barriers not fully sealed.
- Root cause
- Process control
- Action
- Recall notices were sent to customers with a request to return all affected product.
- 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.
- Lot, serial or model codes
- Lot: 56211103, 56211401, 56211704, 57284004
- 510(k) numbers
- ["K121308","K143085"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28