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Terminated

Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

FDA Recall Z-0734-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeFSM
Date Initiated2018-11-28
Date Terminated2020-05-12
Product Quantity971 i nTotal

Reason for Recall

There is a potential for silicone shedding during cleaning and sterilization.

Firm Action

Urgent Medical Device Correction notification letters dated 11/28/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

Official Source

View FDA Recall →

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

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