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Terminated

Strauss Penis Clamp 130MM/General Instruments

FDA Recall Z-1359-2018 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeFHA
Date Initiated2018-02-16
Date Terminated2020-06-30

Reason for Recall

The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Firm Action

An Urgent Medical Device Recall notification will be sent via Fed-ex overnight to our customers on February 16, 2018. Customers will be required to review the recall notification letter in its entirety and ensure all users in the organization are informed about this recall and the affected products

Root Cause

Mixed-up of materials/components

Distribution Pattern

nationwide

Official Source

View FDA Recall →

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

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