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Terminated

VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045

FDA Recall Z-0566-2020 · Posted None

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2016-11-08
Date Terminated2020-11-03
Product Quantity54 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.

K090857VALOR ANKLE FUSION NAIL SYSTEMWrightmedicaltechnologyinc · 2009-07-14

Official Source

View FDA Recall →

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

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