BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut

FDA device recall Z-0609-2018 · posted 2018-02-01 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Cut resistant surgical glove liners lack sterility assurance.

Action taken

1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.

Root cause

Process control

Status

Terminated

Product code

LYU

Quantity affected

1863

Distribution

Distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV and Washington, DC. Distributed to 1 Veteran's Administration h

Date initiated

2017-09-11

Date posted

2018-02-01

Date terminated

2018-08-30

Location

Warsaw, IN

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