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Terminated

INBONE STEM, TIBIAL, TOP, Part Number 200011901

FDA Recall Z-0565-2020 · Posted None

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeHSN
Date Initiated2016-11-08
Date Terminated2020-11-03
Product Quantity65 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.

K051023TOPEZ TOTAL ANKLE REPLACEMENTTopez Orthopedics, Inc. · 2005-11-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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