CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report

Rotation Medical Tendon Staples (narrow recalled by Smith & Nephew

Smith & Nephew is recalling Rotation Medical Tendon Staples (narrow, distributed nationwide in the US. The recall was initiated on 12 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled2961 units (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3097-2024
FDA event ID: 95178
Recalling firm: Smith & Nephew, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Aug 2024
FDA classified: 10 Sep 2024
Reported: 18 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

12 Aug 2024	Recall initiated by company
10 Sep 2024	Classified by FDA	+29 days
18 Sep 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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).

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 95178

Reported	Class	Recall	Company	Reason	Where
18 Sep 2024	CLASS II	Rotation Medical Tendon Staples (broad recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide

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