FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Recall number
- Z-2671-2018
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Status
- Terminated
- Initiated
- 2017-10-24
- Posted
- not on file
- Terminated
- 2023-05-18
- Reason
- Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Root cause
- Under Investigation by firm
- Action
- On October 27, 2017 an URGENT MEDICAL RECALL NOTIFICATION was issued to customers titled Product Field Action PR 1642784. The letter requests that recipients notify all necessary individuals within their organization of the recall and that a Stryker trauma representative will collect any affected product from the customer location. Questions or concerns can be directed to 201-831-6693
- Quantity
- 283
- Distribution
- Distribution US Nationwide.
- Lot, serial or model codes
- 310-0008
- 510(k) numbers
- ["K062898"]
- PMA numbers
- not on file
- Product code
- KWI
- 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