Z-1816-2016 Class II Terminated
FDA device recall Z-1816-2016 was initiated by Biomet, Inc. on Apr 1, 2016 and is designated Class II. 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… The recall status is terminated (terminated May 23, 2017).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2016
- Initiation Date
- Apr 1, 2016
- Termination Date
- May 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
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.
Distribution Pattern
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
Code Information
Part #'s 900360 900364 900360H 900360HI 900363H 900364I Lot #'s 606770 343280 420090 742780 763750 742780 565910 343280
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1816-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026