FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: EVOLVE STEM 8.5MM Model # 496S085
- Recall number
- Z-2989-2020
- Recalling firm
- Wright Medical Technology Inc
- Product
- EVOLVE STEM 8.5MM Model # 496S085
- Status
- Terminated
- Initiated
- 2020-08-26
- Posted
- not on file
- Terminated
- 2021-04-27
- Reason
- Lack of sterility assurance
- Root cause
- Process control
- Action
- Wright initiated a recall on 08/26/2020. It states the following: 1. Immediately cease all use and distribution of this affected lot 2. Immediately quarantine all recalled products you have found, and return all affected product to Wright Medical as soon as possible. 3. Contact Customer Service at 800-238-7117 for return instructions and replacement inventory. 4. If you have further distributed the affected product, please notify the applicable parties . You may copy and distribute this letter and Wright Medical will work directly with them to collect the recalled items. 5. Wright asks you to complete, sign, and return the form as soon as possible. Please return the completed acknowledgement to Wright Medical via email to: Memphis.FieldAction@wright.com within five (5) working days of this notice. If you have further questions, or are aware of any patient issues with these lots, please do not hesitate to contact Customer Service at Wright Medical at 800-238-7117 for more information.
- Quantity
- 16 stems
- Distribution
- USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
- Lot, serial or model codes
- Lot # 1668777
- 510(k) numbers
- ["K060731","K991915"]
- PMA numbers
- not on file
- Product code
- KWI
- 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