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Recall Observatory FDA recall evidence

Device product

ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201

Z-3097-2024

August 12, 2024

Class II

Product summary

Firm
Smith & Nephew Inc.
Event
Event 95178
Status
Ongoing
Classification
Class II
Quantity
2961 units (OUS)
Official record key
device-enforcement:Z-3097-2024

Official wording

Reason: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

Code information: UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152 51192153 51192154 51204480 51204481 51204484 51204485 51204486 51204487 51204488 51204489 51204491 51223193 51223241 51223242 51223243 51223249 51224282

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates/Dubai (UAE).

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incomplete seal