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Recall Observatory FDA recall evidence

Device product

PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116

Z-2036-2017

March 22, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 76934
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2036-2017

Official wording

Reason: This lot of left plates were laser etched and packaged as right plates.

Code information: Lot 16DM15958

Distribution pattern: Internationally to the country of : India

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This lot of left plates were laser etched and packaged as right plates.