Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC…

Date

March 4, 2020

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

Zimmer Surgical Inc

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.

Reason

When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.

Distribution pattern

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.

Quantity

58

Codes and lots

Lot 27968701

Recall started

Jan. 3, 2020

Device type

Tourniquet, Pneumatic

Root cause (FDA)

Process control

What the company told customers

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 CorporateQuality.PostMarket@zimmerbiomet.com.

Recall number

Z-1356-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1356-2020. The agency record governs; check it and the company before acting.