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Open, Classified

Total Knee Pack - Surgical Kit

FDA Recall Z-0864-2022 · Posted None

Recalling FirmStradis Medical, LLC dba Stradis Healthcare
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2022-02-25
Product Quantity76 units

Reason for Recall

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Firm Action

A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution in the states of IN, TX, and PA.

Official Source

View FDA Recall →

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

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