RecallDepth

ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

Company
Wright Medical Technology Inc
Recall Initiated
November 8, 2016
Terminated
November 3, 2020
Recall Number
Z-0563-2020
Quantity
40 units
Firm Location
Arlington, TN

Reason for Recall

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Distribution

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

Lot / Code Info

Lot Number 1568030

Root Cause

Process control

Action Taken

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.

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