FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
- Recall number
- Z-1101-2020
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
- Status
- Terminated
- Initiated
- 2019-12-27
- Posted
- not on file
- Terminated
- 2021-07-23
- Reason
- Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
- Root cause
- Process control
- Action
- The firm initiated the recall by email and letter on 12/27/2019. The notices requests the following actions: Immediately quarantine all recalled products they have and return all affected product to Wright Medical as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.
- Quantity
- 39 devices
- Distribution
- US
- Lot, serial or model codes
- Lot Code 1633010
- 510(k) numbers
- ["K060731"]
- PMA numbers
- not on file
- Product code
- KWI
- Firm FEI
- 3010667733
- Firm city
- Memphis
- Firm state
- TN
- 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