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Recall Observatory FDA recall evidence

Device product

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

Z-1457-2014

February 11, 2014

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 67560
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-1457-2014

Official wording

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

Code information: part no. 399.24, lot number T974302

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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