The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
FDA device recall Z-1457-2014 · posted 2014-04-15 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- 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.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GAD
- Quantity affected
- 20
- Distribution
- Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
- Date initiated
- 2014-02-11
- Date posted
- 2014-04-15
- Date terminated
- 2015-09-10
- Location
- West Chester, PA
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