The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
This recall has been terminated (originally issued April 15, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- February 11, 2014
- Posted
- April 15, 2014
- Terminated
- September 10, 2015
- Recall Number
- Z-1457-2014
- Quantity
- 20
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
Lot / Code Info
part no. 399.24, lot number T974302
Root Cause
Error in labeling
Action Taken
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.
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