Recalls / —
—#177480
Product
SWANSON FINGER JOINT #2, Part Number 4700002
- FDA product code
- KYJ — Prosthesis, Finger, Constrained, Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Number 1574468
Why it was recalled
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Wright Medical Technology, Inc.
- Address
- 11576 Memphis Arlington Rd, Arlington, Tennessee 38002-9497
Distribution
- Distribution pattern
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Timeline
- Recall initiated
- 2016-11-08
- Terminated
- 2020-11-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #177480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.