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Recall Observatory FDA recall evidence

Device product

Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.

Z-2218-2016

June 15, 2016

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 74449
Status
Terminated
Classification
Class II
Quantity
563
Official record key
device-enforcement:Z-2218-2016

Official wording

Reason: The device could be subject to breaches of its sterile packaging.

Code information: Batch numbers: 50412843, 50477278, 50527184

Distribution pattern: Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device could be subject to breaches of its sterile packaging.