Recall Z-1828-2016— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2016-04-01, terminated 2017-05-23. It names 5 FDA 510(k) clearances: K123485, K110879, K110146 and 2 more. Product: Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.. 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..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-01
- Terminated
- 2017-05-23
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
5 on FDA's record- K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
- K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
- K110146 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
- K110145 — BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
- K083070 — TOGGLELOC SYSTEM
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
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.