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Recall Observatory FDA recall evidence

Device product

Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

Z-0265-2022

October 25, 2021

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 88975
Status
Ongoing
Classification
Class II
Quantity
224 units
Official record key
device-enforcement:Z-0265-2022

Official wording

Reason: The labels on the packages of screws were switched.

Code information: REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.

Distribution pattern: Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labels on the packages of screws were switched