CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

Futuro (tm) Sport, Quick Strap Ankle Support recalled

3M Company - Health Care Business is recalling Futuro (tm) Sport, Quick Strap Ankle Support. The recall was initiated on 31 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled158,179 units

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-0945-2018
FDA event ID: 79051
Recalling firm: 3M Company - Health Care Business, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 31 Jan 2018
FDA classified: 9 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

31 Jan 2018	Recall initiated by company
9 Mar 2018	Classified by FDA	+37 days
21 Mar 2018	Published in enforcement report	+12 days

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

Reason for recall

3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6

Where it was distributed

US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots

Where was it sold?

US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

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 79051

This product is part of a recall event; the main page for the event is Ace (tm) Deluxe Ankle Brace recalled by 3M Company - Health Care.

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018	CLASS II	Ace (tm) Deluxe Ankle Brace recalled by 3M Company - Health Care	3M Company - Health Care Business	Foreign Material	MN

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