Recalls / —
—#183269
Product
EVOLVE STEM 8.5MM Model # 496S085
- FDA product code
- KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K060731, K991915
- Affected lot / code info
- Lot # 1668777
Why it was recalled
Lack of sterility assurance
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Wright Medical Technology Inc
- Address
- 11576 Memphis Arlington Rd, Arlington, Tennessee 38002-9497
Distribution
- Distribution pattern
- USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
Timeline
- Recall initiated
- 2020-08-26
- Terminated
- 2021-04-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #183269. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.