ClearanceBrief
Recall Z-0562-2020 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal

Wright Medical Technology, Inc.

SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104

DateNov 8, 2016
StatusTerminated
ReasonThe firm discovered a lack of adequate documentation confirming sterility on certain products.
Root causeProcess control
ActionThe firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
Quantity30 units
DistributionUS and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K864492SWANSON TITANIUM GREAT TOE IMPLANT
Dow Corning Wright, Apr 15, 1987