Recalls / —
—#162691
Product
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
- FDA product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K090857
- Affected lot / code info
- Lot 1608296
Why it was recalled
Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Firm initiated the recall on 03/14/2018 by email communication to distribution centers and distributor consignees, along with a field note to all sales representatives. The firm requested return of the product.
Recalling firm
- Firm
- Wright Medical Technology, Inc.
- Address
- 11576 Memphis Arlington Rd, Arlington, Tennessee 38002-9497
Distribution
- Distribution pattern
- US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
Timeline
- Recall initiated
- 2018-03-14
- Terminated
- 2020-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162691. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.