Recall Z-0609-2018 ยท LYU Accessory, Surgical Apparel
Zimmer Biomet, Inc.
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
| Date | Feb 1, 2018 (initiated Sep 11, 2017) |
| Status | Terminated |
| Reason | Cut resistant surgical glove liners lack sterility assurance. |
| Root cause | Process control |
| Action | 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 question |
| Quantity | 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 hospital in MO. Distributed in Netherland, Peru, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902633 | CUT RESISTANT GLOVE LINER Biomet, Inc., Jul 27, 1990 |