Recall Z-0609-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0609-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-09-11, terminated 2018-08-30. It names one FDA 510(k) clearance: K902633. Product: BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131. Reason: Cut resistant surgical glove liners lack sterility assurance..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-11
Terminated: 2018-08-30
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K902633 — CUT RESISTANT GLOVE LINERBiomet, Inc.·cleared 1990-07-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

Reason for recall

Cut resistant surgical glove liners lack sterility assurance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.