SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
FDA Recall Z-0562-2020 · Posted None
Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeKWD
Date Initiated2016-11-08
Date Terminated2020-11-03
Product Quantity30 units
Reason for Recall
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.