ClearanceBrief
Recall Z-0570-2020 ยท KYJ Prosthesis, Finger, Constrained, Polymer

Wright Medical Technology, Inc.

SWANSON FINGER JOINT #1, Part Number 4700001

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.
Quantity20 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

This recall record lists no 510(k) number.