Device recall: FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Class II FDA enforcement event 79051. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
3M Company - Health Care Business started this device recall on 31 Jan 2018. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class II. FDA event 79051 has 2 product records. The first FDA enforcement report date is 21 Mar 2018. The record gives the status Terminated, with the termination date 11 Feb 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
Recalling firm
3M Company - Health Care Business, Saint Paul, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0945-2018 | FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 | 158,179 units | Class II | Terminated | 21 Mar 2018 |
| Z-0946-2018 | ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 | 162,348 units | Class II | Terminated | 21 Mar 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 29
Other events of the firm
Official channels
- FDA enforcement report Z-0945-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 79051. https://recallregister.com/fda/ii/79051/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
- What quantity of product is in FDA event 79051?
- The event has 2 product records. The first record gives this quantity:
158,179 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.