Recall Z-1828-2016 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
| Date | May 26, 2016 (initiated Apr 1, 2016) |
| Status | Terminated |
| Reason | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection. |
| Root cause | Equipment maintenance |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m. |
| Distribution | Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083070 | TOGGLELOC SYSTEM Biomet Sports Medicine, Dec 16, 2008 |
| K110145 | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR Biomet, Inc., Mar 4, 2011 |
| K110146 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES Tangshan Kaiyue Glove Co., Ltd., May 13, 2011 |
| K110879 | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR Biomet Sports Medicine, Aug 19, 2011 |
| K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF Biomet Sports Medicine, Mar 18, 2013 |