FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
- Recall number
- Z-0569-2020
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
- Status
- Terminated
- Initiated
- 2016-11-08
- Posted
- not on file
- Terminated
- 2020-11-03
- Reason
- The firm discovered a lack of adequate documentation confirming sterility on certain products.
- Root cause
- Process control
- Action
- The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
- Quantity
- 30 units
- Distribution
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- Lot, serial or model codes
- Lot Number 1556150
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1043534
- Firm city
- Arlington
- 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