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

The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.

FDA Recall Z-1457-2014 · Posted 2014-04-15

Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeGAD
Date Initiated2014-02-11
Date Terminated2015-09-10
Product Quantity20

Reason for Recall

The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.

Firm Action

Synthes sent an Urgent Notice: Medical Device Recall letter dated February 11, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Complete the attached Verification Section form. For questions call 610-719-5450.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.

Official Source

View FDA Recall →

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

↑