FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
- Recall number
- Z-1512-2018
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
- Status
- Terminated
- Initiated
- 2018-01-12
- Posted
- not on file
- Terminated
- 2020-05-07
- Reason
- Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
- Root cause
- Error in labeling
- Action
- Branches/Agencies notified by email on 01/16/2018 and were asked to quarantine affected devices. Notification letters and product accountability forms were sent via UPS (with return receipt) on 01/15/2018. Customer notifications were updated and sent to consignees on 03/16/2018 as the technical and medical assessments associated with the issue were completed and additional information related to potential hazards and harms were identified.
- Quantity
- 6 units of catalog 5521-B-400
- Distribution
- Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
- Lot, serial or model codes
- Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
- 510(k) numbers
- ["K141056"]
- PMA numbers
- not on file
- Product code
- MBH
- 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