Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10

FDA Recall Z-0192-2007 · Posted 2006-11-16

Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeHRY
Date Initiated2006-07-18
Date Terminated2007-12-13
Product Quantity12

Reason for Recall

The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003.

Firm Action

The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.

Root Cause

Other

Distribution Pattern

California

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032052UC-PLUS SOLUTION UNICONDYLAR KNEEPlus Orthopedics · 2003-07-25

Official Source

View FDA Recall →

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

↑