Z-1356-2020Class II

Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No...

Name: Z-1356-2020 Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No...
Creator: Zimmer Surgical Inc
Published: 2020-01-03
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2020-01-03 / Terminated / root cause: manufacturing process

FDA source

Zimmer Surgical Inc began a recall of Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547... on 2020-01-03. FDA classified it as Class II and gives the reason as "When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1356-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Posted: 2020-01-28
Terminated: 2020-10-30
Recalling firm: Zimmer Surgical SA
Product: Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.
Product code: KCY Tourniquet, Pneumatic
Reason for recall: When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 3, 2020, the recalling firm distributed recall notices to affected customers via email and FedEx. Customers were instructed to ensure that affected personnel are aware of the contents, and assist the Zimmer Biomet sales representative to locate, quarantine, and return all affected product. If you have questions or concerns regarding this recall, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 58
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.
Product codes and lots: Lot 27968701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1356-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1356-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-25

Product code KCY

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)