Medical DeviceNov 6, 2019
Pajunk GmbH SPROTTE Lumbar with Introducer, labeled as the following: 1 recall — FDA Z-0234-2020
Problem with packaging sealing process which affects sterility.
Class IIFDA: OngoingPajunk GmbH
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Pajunk GmbH as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.