Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200,

FDA device recall Z-1356-2020 · posted 2020-01-28 · Terminated

Recall details

Recalling firm

Zimmer Surgical Inc

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

KCY

Quantity affected

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.

Date initiated

2020-01-03

Date posted

2020-01-28

Date terminated

2020-10-30

Location

Dover, OH