Z-0946-2018Class II

Ace (Tm) Brand, Deluxe Ankle Brace, 207736, Upc 0 51131 20387 7

Name: Z-0946-2018 Ace (Tm) Brand, Deluxe Ankle Brace, 207736, Upc 0 51131 20387 7
Creator: 3M Company - Health Care Business
Published: 2018-01-31
License: https://open.fda.gov/license/

3M Company / initiated 2018-01-31 / Terminated / root cause: labeling and UDI

FDA source

3M Company - Health Care Business began a recall of ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 on 2018-01-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0946-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-31
Posted: 2018-03-09
Terminated: 2021-02-11
Recalling firm: 3M Company
Product: Ace (Tm) Brand, Deluxe Ankle Brace, 207736, Upc 0 51131 20387 7
Product code: IQI Orthosis, Limb Brace
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated their recall by letter on 01/30/2018. The letter stated the following: "Actions required: 1. Immediately discontinue sale of Futuro" Quick Strap Ankle Brace. 2. Isolate or quarantine any stock of the Futuro" Quick Strap Ankle Brace. 3. Call 1-866-746-2524, option #2, Monday to Friday, 8:00 am 4:30 pm Central time, to arrange for the return of the Futuro" Quick Strap Ankle Brace, Cat# 47736EN. 4. If you have further distributed the Futuro" Quick Strap Ankle Brace, please notify any of your customers at once. Please include a copy of this letter in your communications. We apologize for any inconvenience this may cause you. Should you have any questions regarding the product and return process, please feel free to contact 3M Customer Service at 1-866-746-2524, option 2, Monday to Friday, 8:00 am 4:30 pm Central Time."
Quantity in commerce: 162,348 units
Distribution: US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0946-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0945-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09
Z-0946-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code IQI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)